Systems for tracking medications

ABSTRACT

The present disclosure relates to integrated systems, methods and apparatuses for assisting individuals in managing acute life-threatening conditions. A system in accordance with the current disclosure may comprise an electronic circuit configured to be attached to a container of a medication and one or more devices in communication with the electronic circuit in a private network. In an aspect, the one or more devices may work in concert to determine the safety level of an individual based on predetermined usage settings. In some aspects, the system may be configured to determine whether a medication would expire before its manufactured expiry date. In another aspect, the system may assist an individual in locating a medication. In a further aspect, the system may determine whether an individual is having an anaphylactic reaction. In some aspects, the system may detect a known allergen and alert the individual.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. provisional patentapplication No. 62/295,973, filed 16 Feb. 2016 and titled “Systems forTracking Medications”, which is hereby incorporated by reference in itsentirety, including without limitation all appendices.

FIELD OF THE INVENTION

The present disclosure relates to integrated systems, methods, andapparatus that are capable of monitoring the absolute and relativelocations and status of people and objects that are associated with themand to such systems, methods, and apparatus for helping individuals tomanage acute life-threatening conditions such as food allergies, asthma,diabetes, migraines, and the like.

BACKGROUND OF THE INVENTION

This application contains material relating to medical services andmedical information. The provision and handling of some medical servicesand medical information are regulated, as for example, by the UnitedStates Government, the various state governments, and other governmentalagencies within the United States and elsewhere. The disclosure hereinis made solely in terms of logical and financial possibility andadvantage, without regard to possible statutory, regulatory, or otherlegal considerations. Nothing herein is intended as a statement orrepresentation of any kind that any method or process proposed ordiscussed herein does or does not comply with any statute, law,regulation, or other legal requirement whatsoever, in any jurisdiction;nor should it be taken or construed as doing so.

Sometimes, keeping track of people and things is a matter of life anddeath.

Consider severe food allergies, for example. An allergic reaction tofood can affect the skin, the gastrointestinal tract, the respiratorytract, and in the most serious cases, the cardiovascular system.Reactions can range from mild to severe, including the potentiallylife-threatening condition of anaphylaxis. During an anaphylactic event,an individual may have difficulty breathing and experience a drop inblood pressure. Anaphylaxis can result in death if not treatedimmediately with an epinephrine injection.

And food allergies are not particularly rare. To the contrary, accordingto the World Allergy Organization, the burden of food allergies is onthe rise in both developed and developing countries. Worldwide, 240-550million people have food allergies, and it is estimated that, in theUnited States, up to 15 million Americans have food allergies. Thisaffects roughly 1 in every 13 children, which averages to about 2children in every classroom. Further, food allergies in childrenincreased at an alarming rate of approximately 50% between 1997 and2011.

As of this writing, children's food allergies cost nearly S25 billionper year. Among children under the age of 18 in the United States, thislife threatening medical condition has caused more than 200,000 visitsto the emergency room and more than 300,000 ambulatory care visits eachyear. A food allergy reaction sends someone to the emergency room every3 minutes.

Notwithstanding the seriousness of the condition and the immense cost,no clear cause of food allergies has been identified, much less a curefor this medical condition. The only known way to prevent anaphylaxis isa total avoidance of foods that contain the allergen, which is anendless, anxious challenge for the allergic individual.

Once an allergen is consumed, leading to anaphylaxis, epinephrine is theonly life-saving form of treatment. Thus, individuals with foodallergies are advised to carry 2 doses of epinephrine with them at alltimes, but it is often a burden for them and their families or othercaregivers. For example, parents of young children need to make surethere are epinephrine injectors at school and with all daycareproviders. Teenagers may not want to carry the injectors with them dueto inconvenience, shame, bullying, or simple adolescent rebellion. Andpeople forget things.

Further, epinephrine is worthless in an anaphylactic emergency if it isnot administered. A person who may be experiencing signs of an allergicreaction may nonetheless hesitate to administer the epinephrine, maybeout of uncertainty that an anaphylactic reaction has begun or for fearof administering the injection. Individuals with allergies are sometimesnot quite sure when they need to administer epinephrine, especially ifthey have not (to their knowledge) ingested an allergen, and they mayhesitate because they do not want to deal with going to the hospitalafter injecting themselves with epinephrine. Those who do not haveallergies may fear to use an epinephrine injector on someone else.

A number of U.S. patents relate to monitoring locations of portablemedical devices, including U.S. Pat. No. 6,937,150 issued to Medema, etal., on Aug. 30, 2005, which discusses a remote locating servicesituated in an emergency response central dispatch. U.S. PatentApplication Publication 2014/0155827, assigned to Mylan, Inc., discussesan application server configured to periodically receive locationinformation of a medicament device from a mobile device. U.S. PatentApplication Publication 2014/0243749, assigned to Intelliject, Inc.,discusses a monitoring device that assists a patient in determining thelocation of a medicament delivery device and an alarm on the monitoringdevice to alert users of separation from the medicament delivery device.

Nevertheless, none of these patents and patent applications provides areliable and integrated system that provides different levels of alertsand reminders for assisting an individual to manage and use his or hermedication delivery devices across different day-to-day settings.

SUMMARY OF THE INVENTION

Embodiments of the invention relate to systems, methods, and apparatusfor tracking the absolute and relative locations of individuals andobjects that may be associated with them. Although the invention is ofgeneral applicability, embodiments of the invention may be used, e.g.,in connection with medical conditions and devices and/or medicationsintended for use in treating and/or managing the conditions. Thus,embodiments of the invention may help individuals to manage medicalconditions.

According to an embodiment of the invention, a system may help anindividual to manage the use of a medication. The system comprises afirst device configured to adhere to a container of the medication and asecond device configured to communicate wirelessly with the firstdevice. The second device comprises one or more processors and one ormore computer-readable storage media electronically coupled to at leastone of the processors. The computer-readable storage media are encodedwith instructions that cause the second device at least to attempt toform a wireless connection with the first device. The instructionsfurther comprise both (1) instructions that detect success of theattempt to establish a wireless connection with the first device and asa consequence of this detection cause the second device to provideoutput that indicates that the second device is connected to the firstdevice, and (2) instructions that detect failure of the attempt toestablish a wireless connection with the first device and as aconsequence of this detection cause the second device to emit an alert.

In an embodiment of the invention, the container is a medical device. Inan embodiment, the container is an autoinjector. In a furtherembodiment, the autoinjector comprises epinephrine.

In an embodiment of the invention, the second device comprises a locatebutton. When pressed, the locate button causes the second device totransmit a signal to the first device, the signal comprising a commandto the first device to emit sound, light, or both.

In an embodiment of the invention, the first device comprises atemperature sensor. In an embodiment, the first device comprises one ormore processors, one or more memories operatively coupled to at leastone of the processors, and one or more computer-readable storage mediaoperatively coupled to at least one of the processors. Thecomputer-readable storage media is encoded with instructions that, whenexecuted by at least one of the processors, cause the first device atleast to store in at least one of the memories a temperature readingobtained from the temperature sensor, and, based on the temperaturereading, emit a signal from the group that consists of a temperaturewarning signal and temperature damage signal. In an embodiment, thefirst device is configured to emit the temperature warning signal whenthe temperature sensor detects a temperature about 5% outside of apredetermined temperature range. In an embodiment, the first device isconfigured to emit the temperature damage signal when the temperaturesensor detects a temperature about 10% outside of a predeterminedtemperature range.

In an embodiment of the invention, the second device is a base station.In an embodiment, the alarm signal triggers the base station to generatea sound. In an embodiment, the base station comprises a light emittingdiode (LED), and receiving the alarm signal causes the base station toilluminate the LED. In an embodiment, the base station is configured tohold more than one type of medical devices.

In an embodiment of the invention, the second device is a wearable. In afurther embodiment, the wearable comprises a vibration module, and instill a further embodiment, the alarm signal activates the vibrationmodule. In an embodiment, the wearable comprises an audible alarm, andin a still further embodiment, the alarm signal activates the audiblealarm.

In an embodiment of the invention the second device is a mobile phone.In an embodiment, the signal is communicated by the mobile phone to asupport infrastructure.

In an embodiment of the invention, the second device is a wearable or abase station, and the system comprises a third device configured tocommunicate with the second device. The third device comprises one ormore processors and one or more computer-readable storage mediaoperatively coupled to at least one of the processors. Thecomputer-readable storage medium is encoded with instructions that, whenexecuted by at least one of the processors, cause the third device atleast to try to establish a connection with the second device, determinethe last visible location of the first device if a connection cannot beestablished, record the location of the first device if a connection isestablished, and report the location to a cloud server. In anembodiment, the third device is a mobile phone.

In an embodiment of the invention, the second device is a wearable or abase station, and the system comprises a third device configured tocommunicate with the second device. The third device comprises one ormore processors and one or more computer-readable storage mediaoperatively coupled to at least one of the processors. Thecomputer-readable storage media are encoded with instructions that, whenexecuted by at least one of the processors, cause the third device atleast to establish a connection with a support infrastructure,determine, using the connection with the support infrastructure, whetherthe second device is in a safe zone, and provide, via the supportinfrastructure, a notification to the second device if the second deviceis determined to be outside of the safe zone.

In an embodiment, the safe zone is defined by a geographical location.In an embodiment, the safe zone is defined by a geographical locationand a time schedule. In an embodiment, the third device is a mobilephone.

Although the invention may be discussed here primarily in connectionwith embodiments related to medical conditions and related devices andmedications, the invention is not limited to such embodiments. To thecontrary, embodiments of the invention may be applicable to variousdifferent circumstances in which it may be useful to track, e.g., thelocation and/or status of a person and an object.

For example, according to an embodiment of the invention, a system mayenable monitoring, e.g., of a courier carrying sensitive information. Afirst electronic circuit or device may be affixed to a container (e.g.,a briefcase or satchel) holding papers and/or computer-readable media. Asecond device may be configured to attempt to connect to the firstdevice and to indicate whether the connection was successful, possiblycausing an alert or alarm if the connection is not successful.

Similarly, in an embodiment of the invention, a system may help prevent,e.g., accidentally leaving an infant behind in a car. A first electroniccircuit or device may be configured, e.g., to be worn securely butcomfortably by the child. A second device may be configured to attemptto connect to the first device and to indicate whether the connectionwas successful, possibly causing an alert or alarm if the connection isnot successful. The first device may in an embodiment of the inventionincorporate, e.g., a temperature sensor and may transmit informationreflecting temperature measurements.

BRIEF DESCRIPTION OF THE DRAWINGS

Some aspects of the disclosure are herein described, by way of exampleonly, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and are for purposes ofillustrative discussion of embodiments of the disclosure. In thisregard, the description, taken with the drawings, make apparent to thoseskilled in the art how aspects of the disclosure may be practiced.

FIG. 1 depicts elements of a system and possible paths of communicationbetween them according to an embodiment of the invention.

FIG. 2. depicts schematically a network architecture of a systemaccording to an embodiment of the invention.

FIG. 3 depicts a sticker according to an embodiment of the invention.

FIG. 4 is an exploded view of a sticker according to an embodiment ofthe invention.

FIGS. 5 and 6 are circuit schematics of an exemplary sticker accordingto an embodiment of the invention.

FIG. 7 depicts a container that may perform functions of a stickeraccording to an embodiment of the invention.

FIG. 8 depicts a wearable according to an embodiment of the invention.

FIGS. 9, 10A, and 10B are circuit schematics for a wearable according toan embodiment of the invention.

FIG. 11 depicts a home base station according to an embodiment of theinvention.

FIGS. 12, 13, 14, 15, and 15A are circuit schematics of an exemplaryhome base station according to an embodiment of the invention.

FIG. 16 depicts a public base station according to an embodiment of theinvention.

FIG. 14 depicts [something about the software of the public basestation]

FIG. 15 depicts schematically software components of a mobile appaccording to an embodiment of the invention.

FIG. 16 depicts a user interface screen for a mobile app according to anembodiment of the invention.

FIGS. 17-26 depict user interface screens for a mobile app according toan embodiment of the invention.

FIG. 27 depicts a flow of activating a sticker according to anembodiment of the invention.

FIG. 28 depicts a user interface screen for a mobile app according to anembodiment of the invention.

FIG. 29 depicts a flow of activating a base station according to anembodiment of the invention.

FIG. 30 depicts a flow of activating an emergency on a mobile appaccording to an embodiment of the invention.

FIGS. 31-34 depict user interface screens for a mobile app according toan embodiment of the invention.

FIGS. 35A, 35B, 35C, and 35D illustrate an exemplary system use scenarioas described in Example 1.

FIGS. 36A, 36B, 36C, 36D, and 36E illustrate an exemplary system usescenario as described in Example 2.

FIGS. 37A, 37B, 37C, 37D, and 37E illustrate an exemplary system usescenario as described in Example 3.

FIGS. 38A, 38B, 38C, and 38D illustrate an exemplary system use scenarioas described in Example 4.

FIGS. 39A, 39B, 39C, 39D, and 39E illustrate an exemplary system usescenario as described in Example 5.

FIGS. 40A, 40B, 40C, 40D, and 40E illustrate an exemplary system usescenario as described in Example 6.

FIGS. 41A, 41B, 41C, 41D, and 41E illustrate an exemplary system usescenario as described in Example 1.

DETAILED DESCRIPTION

This description is not intended to be a detailed catalog of all thedifferent ways in which the disclosure may be implemented, or all thefeatures that may be added to the instant disclosure. For example,features illustrated with respect to one embodiment may be incorporatedinto other embodiments, and features illustrated with respect to aparticular embodiment may be deleted from that embodiment. Thus, thedisclosure contemplates that in some embodiments of the disclosure, anyfeature or combination of features set forth herein can be excluded oromitted. In addition, numerous variations and additions to the variousembodiments suggested herein will be apparent to those skilled in theart in light of the instant disclosure, which do not depart from theinstant disclosure. In other instances, well-known structures,interfaces, and processes have not been shown in detail in order not tounnecessarily obscure the invention. It is intended that no part of thisspecification be construed to effect a disavowal of any part of the fullscope of the invention. Hence, the following descriptions are intendedto illustrate some particular embodiments of the disclosure, and not toexhaustively specify all permutations, combinations and variationsthereof.

Unless explicitly stated otherwise, the definition of any term herein issolely for identification and the reader's convenience; no suchdefinition shall be taken to mean that any term is being given anymeaning other than that commonly understood by one of ordinary skill inthe art to which this disclosure belongs, unless the definition hereincannot reasonably be reconciled with that meaning. Further, in theabsence of such explicit definition, all technical and scientific termsused herein have the same meaning as commonly understood by one ofordinary skill in the art to which this disclosure belongs. Theterminology used in the description of the disclosure herein is for thepurpose of describing particular embodiments only and is not intended tobe limiting of the disclosure.

All publications, patent applications, patents, and other referencescited herein are incorporated by reference in their entireties for theteachings relevant to the sentence and/or paragraph in which thereference is presented. References to techniques employed herein areintended to refer to the techniques as commonly understood in the art,including variations on those techniques or substitutions of equivalenttechniques that would be apparent to one of skill in the art.

Unless the context indicates otherwise, it is specifically intended thatthe various features of the disclosure described herein can be used inany combination. Moreover, the present disclosure also contemplates thatin some embodiments of the disclosure, any feature or combination offeatures set forth herein can be excluded or omitted.

The methods disclosed herein comprise one or more steps or actions forachieving the described method. The method steps and/or actions may beinterchanged with one another without departing from the scope of thepresent invention. In other words, unless a specific order of steps oractions is required for proper operation of the embodiment, the orderand/or use of specific steps and/or actions may be modified withoutdeparting from the scope of the present invention.

As used in the description of the disclosure and the appended claims,the singular forms “a”, “an”, and “the” are intended to include theplural forms as well, unless the context clearly indicates otherwise.

As used herein, “and/or” refers to and encompasses any and all possiblecombinations of one or more of the associated listed items, as well asthe lack of combinations when interpreted in the alternative (“or”).

The term “about,” as used herein when referring to a measurable valuesuch as distance and the like, is meant to encompass variations of ±20%,±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of the specified amount.

As used herein, phrases such as “between X and Y” and “between about Xand Y” should be interpreted to include X and Y. As used herein, phrasessuch as “between about X and Y” mean “between about X and about Y” andphrases such as “from about X to Y” mean “from about X to about Y.”

The terms “comprise,” “comprises”, and “comprising”, as used herein,specify the presence of the stated features, integers, steps,operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, integers, steps,operations, elements, components, and/or groups thereof.

The term “computer-readable storage medium”, as used herein,specifically does not refer to transitory propagating signals.

As used herein, the transitional phrase “consisting essentially of”means that the scope of a claim is to be interpreted to encompass thespecified materials or steps recited in the claim and those that do notmaterially affect the basic and novel characteristic(s) of the claimeddisclosure. Thus, the term “consisting essentially of”, when used in aclaim of this disclosure, is not intended to be interpreted to beequivalent to “comprising”.

As used herein, the term “subject” refers to an individual who has amedical condition such as, but not limited to, a food allergy, diabetes,asthma, and/or migraines.

As used herein, the term “team” refers to a group of individualsassociated with a subject through the systems as described herein.

As used herein, the term “team member” refers to any individual in ateam associated with a subject.

As used herein, the term “public user” refers to an individual who is ateam member in another team.

As used herein, the term “recipient” refers to an individual whoreceives shared information, but is not a team member of any teams.

As used herein, the term “paired” refers to the establishment of aconnection between two devices to form the systems as described herein.

As used herein, the term “connected” refers presence of communicationbetween at least two devices in the systems described herein, includingtransmitting or receiving a signal.

As used herein, the term “epinephrine pen” refers a single dose ofepinephrine provided in an autoinjector in accordance with the presentdisclosure.

As used herein, the term “home” refers to a reference starting location.It does not necessarily refer to the home at which a subject resides.

As used herein, the term “cloud” refers to one or more computer serversthat are built, hosted, and delivered through a platform over internetaccording to the present disclosure.

As used herein, the term “wearable” refers to an electronic device thatis worn by an individual.

As used herein, “prevention” or “preventing,” with respect to acondition or a disease, is an approach for reducing the risk ofdeveloping a condition or a disease before it manifests in a patient.Prevention approaches include, but are not limited to: identifying adisease at its earliest stage so that prompt and appropriate managementcan be initiated, protecting a tissue prone to a condition or a diseaseprior to its manifestation, reducing or minimizing the consequences of adisease, and a combination thereof.

As used herein, “treatment” or “treating”, with respect to a conditionor a disease, is an approach for obtaining beneficial or desired resultsincluding preferably clinical results after a condition or a diseasemanifests in a patient. Beneficial or desired results with respect to adisease include, but are not limited to, one or more of the following:improving a condition associated with a disease, curing a disease,lessening severity of a disease, delaying progression of a disease,alleviating one or more symptoms associated with a disease, increasingthe quality of life of one suffering from a disease, prolongingsurvival, and a combination thereof. Likewise, for purposes of thisdisclosure, beneficial or desired results with respect to a conditioninclude, but are not limited to, one or more of the following: improvinga condition, curing a condition, lessening severity of a condition,delaying progression of a condition, alleviating one or more symptomsassociated with a condition, increasing the quality of life of onesuffering from a condition, prolonging survival, and a combinationthereof.

Embodiments of the invention discussed here may relate primarily topersons with potentially life-threatening medical conditions and devicesfor administration of medications. Those embodiments may relate morespecifically to persons with severe food allergies and epinephrineautoinjectors. But it will be appreciated that the invention is notlimited such circumstances, and embodiments of the invention may relateto any analogous circumstance in which it is wished to track therelative and absolute locations of two or more persons and/or objectsand possibly take one or more automated actions based on detectedchanges in the status and/or locations of some or all of the trackedpersons and/or objects.

In connection with an embodiment, a medication may be contained in acontainer. For example, the container may be a medical device or,alternatively, an enclosure that contains a medical device. For thispurpose, a medical device may be, e.g., an autoinjector, an injector, oran inhaler, but may be another device or type of device.

In an embodiment of the invention, the medical device may be anautoinjector filled with injectable epinephrine. As used herein,“epinephrine” refers to a natural or synthesized compound that binds toa variety of adrenergic receptors, including but not limited to themajor subtypes α₁, α₂, β₁, β₂, and β₃. Epinephrine may be racemic ornon-racemic. Epinephrine may be used to treat medical conditionsincluding, but not limited to, anaphylaxis.

In connection with some embodiments of the invention, a single dose ofinjectable epinephrine may be provided in commercially available formsincluding but not limited to, an EpiPen®, an Auvi-Q®, an Allerject®, anAdrenaclick, or a Twinject®.

In connection with other embodiments of the invention, the medicaldevice may be an inhaler filled with bronchodilators including, but notlimited to, salbutamol, albuterol, levosalbutamol, levalbuterol,pirbuterol, epinephrine, ephedrine, terbutaline, salmeterol,clenbuterol, formoterol, bambuterol, and indacaterol. In connection withother embodiments, the medical device may be an injector or autoinjectorfilled with insulin, which may be long-acting or short-acting. Inconnection with other embodiments of the invention, the medical devicemay be an injector or an autoinjector filled with epilepsy medications,including, but not limited to, lorazepam, fosphenytoin sodium, valproatesodium, phenytoin, adrenocorticotropin hormone (ACTH), and diazepam. Inconnection with other embodiments of the invention, the medical devicemay be an injector or an autoinjector filled with migraine medicationsincluding, but not limited to, ergotamine, dihydroergotamine,chloropromazine, droperidol, haloperidol, metoclopramide,prochlorperazine, sumatriptan, nonsteroidal anti-inflammatory drug(NSAIDs), merperidine, nalbuphine, and tramadol.

FIG. 1 depicts, conceptually, interacting components of a system 100 fortracking medication according to an embodiment of the invention. Asdepicted, a system 100 may include one or more “stickers” 120, which maybe devices that are intended to adhere, e.g., to medication containers(not pictured). In an embodiment of the invention, a sticker 120 may becapable of transmitting information, which may include informationrepresenting the identity and status of the sticker 120 and/or themedication and/or medication container that it adheres to. A sticker 120in an embodiment may also be capable of emitting, e.g., sound and orlight in response to a signal, to aid in locating the medicationcontainer.

A system 100 may also include one or more “wearables” 130, which, as thename suggests, may be devices designed, e.g., to be worn by a subjectand/or clipped or otherwise removably attached to clothing or otherarticle worn by a subject. A wearable 130 in an embodiment of theinvention may be configured, e.g., to attempt to detect signals from oneor more stickers 120, thereby indicating proximity of the sticker 120and the wearable 130. The wearable 130 may also be capable in anembodiment of transmitting information, e.g., to cause at sticker 120 toemit light and/or sound, and/or to indicate the location of or otherinformation about the wearer.

In an embodiment of the invention, a mobile application (“app”) 140 on adevice such as, e.g., a smartphone, may support and/or coordinateoperation of the system for one or more persons, including, e.g., one ormore subjects. A system may also include one or more home base stations150 and/or one or more public base stations 160. Operation of the systemmay be coordinated, e.g., by a network-based server infrastructure 170.

FIG. 1 should be understood to depict types of elements, some or all ofwhich may exist in a system 100 according to embodiments of theinvention. Multiples of any or all depicted elements may exist, operate,and interoperate in an embodiment of the invention. For example, inconnection with an embodiment of the invention, thousands of subjectsmay have the mobile app 140 installed on their respective mobiledevices, while each subject may have one or more wearables 130, one ormore home base stations 150 and multiple stickers 120. Other home basestations 150 and/or public base stations 160.

According to embodiments of the invention, communication paths may existbetween elements, including elements of different types. For example, inan embodiment such as FIG. 1 depicts, stickers 120 may communicate withwearables 130, mobile apps 140, home base stations 150, and public basestations 160. In FIG. 1, these paths are depicted by dashed arrows 180,indicating that in the depicted embodiment, the communication betweendevices takes place over a short-range connection that is directlybetween the devices, using, e.g., Bluetooth® Low Energy.

Similarly, in an embodiment such as FIG. 1 depicts, a home base station150 may communicate with stickers 120, wearables 130, mobile apps 140,and the support infrastructure 170. Again, as depicted, dashed arrows180 indicate short-range direct connections. Further, the solid arrows185 connecting the home base station 150 with the mobile app 140 and thesupport infrastructure 170 indicate connections via a network such as,e.g., a wired or wireless LAN or the Internet.

It will be appreciated that FIG. 1 merely depicts possible communicationpaths according to an exemplary embodiment of the invention. Except asexplicitly disclosed herein, devices may potentially be capable of anyone or more communication methods or pathways consistent with the natureand purpose of the devices.

FIG. 2 depicts a simplified network architecture 200 to furtherillustrate conceptually potential methods and paths of interactionaccording to embodiments of the invention. For example, in a home 210, asticker 214 may communicate, e.g., via Bluetooth® Low Energy with awearable 218, a home base station 222, and an app 226 on a mobiledevice. The wearable 218 may additionally and similarly communicate withthe home base station 222 and the app 226. The home base station 222 andapp 226 may further be in communication with each other and with othercomponents, including, e.g., the support infrastructure 230, via, e.g.,the Internet 240.

It will be appreciated that other communication paths and methods may beused within a home 210 in addition to or instead of some or all of thedepicted paths. For example, the home base station 222 may communicate(not pictured) with the app 226 on the mobile device, e.g., via a sharedwired or wireless network (not pictured), a Bluetooth® connection (notpictured), a USB connection (not pictured), and/or any other convenientmethod.

FIG. 2 also depicts a public location 250, such as, e.g., a restaurant.An app 254 at this location 250 may communicate with a public basestation 258 and via the Internet 240 with other components. A group ofstickers 262 may communicate with the public base station 258, an app266 on a second mobile device, and a wearable 270, all of which may alsocommunicate with each other. The public base station 258 and the app 266may also communicate with other components via the Internet 240.

FIG. 2 further depicts two other apps 280, 284 on other devices atunspecified locations, which communicate with other components,including, e g., the support infrastructure 230 via the Internet 240.

It bears repeating that FIG. 2 depicts merely a simplified set ofdevices and communication paths for the purpose of illustrating theprinciples that may operate in an embodiment of the invention. In anembodiment of the invention, other pathways and/or protocols may be usedin addition to or instead of any one or more depicted pathways, and inany or all of the depicted roles.

FIG. 3 depicts a sticker 120 according to an embodiment of theinvention, viewed from the front (a), one side (b), and one end (c). Inembodiments of the invention, the dimensions of the sticker 120 mayreflect the size of its components, but may also reflect a desire tominimize (or at least reduce) the bulk that the sticker 120 adds whenaffixed to a container. In embodiments, sticker 120 may be of a size andor shape chosen to not cover any medical label information on thecontainer.

In an embodiment, the sticker 120 may comprise an adhesive, e.g.,affixed to the underside 310 of the sticker 120, that allows the sticker120 to permanently or removably (depending on the embodiment) adhere tothe container. The underside 310 may in an embodiment be shaped tofacilitate adhesion of the sticker 120 to the container. For example, inan embodiment, the underside 314 may be curved to enhance adhesion to acurved medication container, while in an embodiment, the underside 318may be flatter to enhance adhesion to a correspondingly shapedcontainer.

A sticker 120 in an embodiment such as FIG. 3 depicts may have twobuttons on the front: an emergency button 330 and a cancel/pair button334. In an embodiment of the invention, a subject may trigger anemergency alert (discussed further below) by pressing the emergencybutton 330. It will be appreciated that, to reduce the chance of falsealarms, a sticker 120 may be configured not to signal an emergencyimmediately, but only after the emergency button 330 has been held downfor a predetermined interval. For example, in an embodiment of theinvention, a sticker 120 may not signal an emergency until the emergencybutton 330 has been held down for at least 3 seconds.

In an embodiment of the invention, once an emergency has been signaled,the alert may be canceled by pressing the cancel/pair button 334. Asbefore, to prevent accidental cancellation of the alert during an actualemergency, the sticker 120 may be configured to require that thecancel/pair button 334 be held down continuously for a predeterminedinterval. For example, in an embodiment of the invention, the stickermay not cease indicating the emergency until the cancel/pair button 334has been held down for at least 3 seconds.

The cancel/pair button 334 may also be used to pair a sticker, e.g.,with a mobile device or an app on that device, e.g., as describedelsewhere in this document.

A sticker 120 in an embodiment of the invention may also be configuredto emit light, e.g., during an emergency or, on request, as a way tohelp find the sticker and the medication container it is attached to.For example, in an embodiment of the invention, a red LED light pipe 340may emit light from the top of the sticker 120 when suitably powered.

As already described, a sticker 120 according to embodiments of theinvention may communicate with other devices. In an embodiment of theinvention, a sticker may be configured to use Bluetooth® Low Energy(BLE) technology to communicate with other devices. BLE, which is wellknown in the art, is a technology for wirelessly creating ad hocnetworks of electronic devices. (The name reflects the fact that BLEconsumes less energy than its predecessors.) To be detected, a BLEdevice broadcasts advertising packets, which other BLE devices scan for.When a scanner detects an advertising packet, it may respond and beginnegotiating a link between itself and the source of the packet.

iBeacon™ is a protocol promoted as a technology for location andproximity detection. A device that uses iBeacon™ emits BLE advertisingpackets that follow a strict format that is defined in the protocol. Asit is typically used, an iBeacon™ device periodically broadcasts theseadvertising packets that include information that uniquely identifiesthe device. A device such as a smartphone that receives the packet maydetermine from that fact that it is near the iBeacon™, and therebydeduce its own location based on the known location of the iBeacon™.

According to the iBeacon™ standard, the identifying information in anadvertising packet comprises a 16-byte Universally Unique Identifier(UUID), a 2-byte major ID, and a 2-byte minor ID. As conventionallyused, the UUID is unique to the user, the major ID identifies theuser-defined group of devices that includes the particular iBeacon™, andthe minor ID identifies the particular iBeacon™ within that group.

Thus, for example, devices using the iBeacon™ protocol may be placedthroughout a department store; the UUID may identify the store or storeowner, the major ID of a particular iBeacon™ may identify the floor onwhich the device has been placed, and the minor ID may identify theparticular iBeacon™ on that floor. The department store may also offeran app to its customers. The app, when used within the store, may usethe identifying data of the device or devices detected at any locationto find the user's location within the store and then use thisinformation, e.g., to give the user directions to some other specifiedpart of the store.

A sticker 120 in embodiments of the invention may broadcast one or moresignals or types of signals to make its presence discoverable by otherdevices. In one embodiment, a sticker 120 may include a communicationmodule configured to transmit signals using the iBeacon® protocol. Insuch an embodiment, the UUID and Major ID may identify, e.g., the deviceand the subject. But in embodiments of the invention, the identificationdata in the minor ID may be changed, according to programming in thedevice, to provide certain information about the device.

For example, in an embodiment of the invention, the minor ID may be usedto signal, e.g., whether the sticker 120 is signaling an emergency,whether the battery is low, whether the ambient temperature puts themedication at risk, and/or whether the device (and therefore themedication) has been exposed to temperatures such that the medication ormedication container may be damaged and possibly unusable. Table 1presents, in the form of hexadecimal numbers, values that may beassociated with each of these conditions: in an embodiment, a sticker120 using iBeacon™ may broadcast a minor ID that is a logical OR of thevalues associated with each applicable state, with a minor ID of zeroindicating that none of listed conditions applies.

TABLE I Exemplary Minor ID mapped to various sticker device statusesData Sets Communicated Data Type To/From Cloud (in hexadecimal)Emergency state Minor ID 0x01 Low battery state (<25%) Minor ID 0x02Temperature at risk state Minor ID 0x04 Temperature damaged state MinorID 0x08 Find My Pen state Minor ID 0x10

Thus, for example, emergency state (0x01) and low battery state (0x02)may be transmitted as 0x03. If the emergency is subsequently canceled,the low battery state may still apply, so the broadcast minor ID maychange from 0x03 to 0x02 to reflect the cancellation.

It will be appreciated that in embodiments of the invention, a Minor IDas described above may be used to encode any desired information,including, e.g., information about the state and/or of the transmittingdevice, consistent with the requirements of the applicable protocol orprotocols.

It will be appreciated that a subject may suffer a serious orpotentially life-threatening episode while in possession of a medicationcontainer with a sticker 120 attached. For example, due to a severe foodallergy, a subject may carry an epinephrine autoinjector with a sticker120 attached. In case of exposure to an allergen or onset of symptoms ofanaphylaxis, the subject may wish to summon help and/or to alertcaregivers, in addition to administering the epinephrine. Thus, in sucha circumstance, in connection with an embodiment of the invention, thesubject or other person may press the emergency button 330 on thesticker, e.g., as described above.

In response, the sticker may change the state information that itbroadcasts using iBeacon™ to reflect the emergency, and this change maybe detected and acted upon, e.g., as described below. But in anembodiment of the invention, the sticker may also be configured toattract attention locally, e.g., by emitting sound and or light. Forexample, a sticker 120 may include a light pipe 340 that may, e.g.,brightly flash red. In addition to or instead of the light, a sticker120 in an embodiment of the invention may be configured to make a loudnoise, e.g., by including a buzzer.

It will be appreciated that transmitting iBeacon™ broadcasts consumesenergy. To improve battery life, in an embodiment of the invention, avariable broadcast interval may be used. In an exemplary embodiment ofthe invention, the broadcast interval may be set by an algorithm suchas: 1) start with a broadcast interval of 60 seconds; 2) if notconnected to BLE central within 1 hour, increase broadcast interval to120 seconds; 3) if not connected to BLE central within 3 hours, increasebroadcast interval to 180 seconds; 4) upon connection with BLE central,if broadcast interval is greater than 60 seconds, reduce broadcastinterval to 60 seconds.

In addition to its iBeacon™ function, a sticker 120 according to anembodiment of the invention may also operate in BLE connected devicemode, e.g., to enable receipt of commands, such as the command to enter“Find My Pen” mode. For example, in an embodiment, a sticker 120 mayaccept commands, e.g., to enter and exit emergency mode, to activate andcancel “Find My Pen” state, to enter setup state, to tag the medicationas damaged and/or expired, and to alter the iBeacon advertisinginterval.

FIG. 4 depicts a circuit board 400 inside a sticker 120 according to anembodiment of the invention. In an embodiment such as FIG. 4 depicts,power is provided by two lithium coin cells 410 in contact with thecircuit board 400, each held in position by a clip 414. In oneembodiment, the batteries 410 may be non-rechargeable 3-volt CR1616cells.

As depicted, the upper side 418 of the circuit board 400 includes abuzzer 422 and two switches 426, 430 that are aligned to be actuated bythe emergency button 330 and the cancel/pair button 334.

As FIG. 4 depicts, various circuit components are visible on theunderside 450 of the circuit board 400. FIGS. 5 and 6 depict circuitschematics for a sticker 120 according to an exemplary embodiment of theinvention.

In an embodiment such as FIG. 5 depicts, core logic and wireless systems500 may be implemented, e.g., by a Bluetooth® system-on-chip (“SoC”) 510such as the nRF51422 or nRF51822, both of which are SoCs madecommercially available by Nordic Semiconductor.

FIG. 6 depicts circuit schematics for additional systems implemented ona circuit board 400 in a sticker 120 in an embodiment of the invention.As depicted, The batteries provide power in connection with batteryinput circuitry 530, and a fuel gauge 520 circuit measures the voltageprovided by the batteries 410 and provides this measurement to an analoginput of the SoC 510. FIG. 6 also depicts circuits for the buttons 540,the buzzer 550, the indicator LED 560, and programming pins 570,according to an embodiment of the invention. Although not depicted,ambient temperature may be measured by any appropriate means; in anembodiment of the invention, it may be measured, e.g., with reference toan on-die temperature sensor incorporated in the SoC 510.

It will be appreciated that in embodiments of the invention, thefunctions of a sticker 120 may be performed by a device that differs inshape and/or implementation from that described above. For example, asdisclosed, a sticker 120 according to embodiments of the invention maybe powered, e.g., by non-rechargeable lithium coin cells 410, and thesecells 410 may, e.g., be sealed within the case of the sticker 120 suchthat they cannot reasonably be replaced by an end user. In otherembodiments of the invention (not pictured), the sticker 120 may, forexample, provide means for the user to replace the batteries 410.

In still other embodiments of the invention, a sticker 120 may bepowered by one or more rechargeable batteries (not pictured). In suchembodiments, the circuits may include, e.g., one or more ports (such as,for example, a micro-USB port) that allow external power to be supplied,and one or more circuits that, e.g., apply this power to recharge thebatteries.

In connection with an exemplary embodiment described above, the expecteduseful life of the cells 410 within a sticker 120 had been determinedthrough experiment to be roughly the same as the expected useful life ofan epinephrine autoinjector that the sticker 120 might be attached to,and therefore the remaining lifetime of the cells 410 may be used insuch an embodiment as a proxy for the time until expiry of themedication in the autoinjector. It will be appreciated that inalternative embodiments in which the batteries may be replaced and/orrecharged, the time to expiry may be calculated differently, e.g., byincluding a real-time clock and measuring the actual time since theautoinjector was acquired.

In embodiments of the invention, a sticker 120 may be associated withthe medication container through a means other than adhesion. (Unlessexplicitly stated otherwise or required by context, “sticker” may referherein to devices according to embodiments of the invention that performthe functions and/or roles of a sticker 120, even though, in anembodiment, a particular device may not be intended literally to stickto a tracked object.) For example, in an embodiment of the invention,for a suitably shaped medication container or other object, a sticker120 may be attached to the object, e.g., with a cable tie or similarmechanism (not pictured) or, removably, e.g., with a carabiner or otherclip (not pictured).

FIG. 7 depicts a container 700 in an embodiment of the invention withcircuitry built into it that performs the functions of the sticker 120.The outside of the container 700 in such an embodiment may provide,e.g., an emergency button 710 and a cancel/pair button 714 that functionas described above, and may be capable of emitting light and/or sound,also as described above.

The container 700 may be capable of containing, e.g., an epinephrineautoinjector or other tracked object 716, which may in an embodiment bekept in the container 700, e.g., by a removable cap 718. In such anembodiment, the container 700 may be configured so that removing the captriggers an emergency, e.g., as previously described.

In some embodiments, a sticker 120 may also enable securely andanonymously retrieving lost medical devices or be supplied with othermeans for doing so. For example, in an embodiment, a label (notpictured) may be provided, e.g., printed on the sticker 120 or as aseparate object to be applied to the container. The label may instruct afinder to put the medication container into a mailbox, upon which themedication container may be forwarded to a central dispatch. The labelmay also provide a bar code or other computer-readable identifier, thatmay, e.g., be scanned upon receipt at the central dispatch to identifythe owner of the medication container, which may then be returned to theowner. Alternatively, the owner may be identified by comparing theinformation broadcast by the sticker 120 according to the iBeacon®protocol with information about registered devices.

According to embodiments of the invention, the location of the stickermay be monitored as a proxy for monitoring the location of theautoinjector or other object to which it is attached. A smartphone orsimilar mobile device may be a suitable observer of stickers' locationsbecause it may be capable of interacting with stickers, e.g., viaBluetooth® and/or similar technologies and also capable of interactingwith remote system components, e.g., via a wireless Internet connection.

But embodiments of the invention may serve, e.g., to help parentsmonitor children's possession of autoinjectors. It will be appreciated,however, that many children do not carry smartphones. Thus, inembodiments of the invention, a wearable device may observe thestickers' locations. Such a device may, for example, provide a referencefor a child's location, enabling determination whether the child is withour without their medication/sticker. The observation of the wearablemay thus be considered to be an observation of the child.

A wearable according to embodiments of the invention may act as aseparate battery-powered observer that a child could carry, e.g., toschool. Depending on the embodiment, a wearable may or may not haveindependent capabilities for connecting, e.g., to the Internet. But,once configured to be paired with one or more stickers, a wearable mayimplement “leash” functionality, according to which it may keep track ofwhether any such stickers are nearby and, e.g., alert the child whowears the wearable if no sticker is seen.

FIG. 8 depicts a wearable 130 according to embodiments of the invention.In views (a) and (b), the depicted wearable 130 includes a strap 810,which may permit a subject to wear the wearable 130, e.g., around thewrist, in the manner of a wristwatch. In view (c), the wearable 130includes a clip 814, which may allow the wearable 130 to be attached,e.g., to a garment the subject is wearing. It will be appreciated that awearable 130 in an embodiment of the invention may be configured to beremovably attachable, e.g., to a strap 810 and/or a clip 814, which mayallow a subject to change how the wearable 130 may be worn.

A wearable 130 in an embodiment of the invention may have buttons. Forexample, in an embodiment, a wearable 130 may have an emergency button830 and/or a cancel/pair button 834, which may, e.g., respond similarlyto the corresponding buttons 330, 334 (FIG. 3) of a sticker 120. Awearable 130 (FIG. 8) in emergency status may behave similarly to asticker 120 in emergency status, e.g., by emitting light and/or soundand/or sending an emergency signal to one or more other devices, asdescribed below.

In an embodiment, a wearable 130 may further comprise a locate button838, e.g., as FIG. 8 depicts. According to embodiments of the invention,pressing the locate button 838 may cause the wearable to transmit, e.g.,one or more signals that may be received by any or all stickers 120 thatare paired with the wearable 130 and near to it. The meaning of “near”in this context may depend, e.g., on the effective range transmissionprotocol and/or the environment (e.g., indoors vs. outdoors), but in anembodiment that uses BLE, the effective range may be just that rangethat, in a particular environment, allows a BLE connection between awearable and a sticker.

A sticker 120 that receives the signal may respond, e.g., by enteringfindable mode as described above.

A wearable 130 in an embodiment of the invention may be powered by oneor more rechargeable batteries. Accordingly, a wearable 130 may provideone or more ports, such as a USB-micro port 850, through which thewearable 130 may receive power.

According to embodiments of the invention, a wearable 130 may be capableof finding its location in one or more ways. For example, it may be ableto determine its location relative to one or more other devices withknown locations (such as, e.g., base stations and/or checkpoint devicessuch as are described below) using a protocol such as iBeacon®. In anembodiment, the wearable may similarly be able to find its location bydetecting, e.g., nearby Wi-Fi® networks with known locations. Otherpossible ways for a wearable 130 to determine its location according toembodiments of the invention may include, e.g., cell tower triangulationand/or built-in GPS.

In some embodiment, a smart wearable the second smartphone may furthercomprise a set of status lights to indicate the safe zone in which anindividual is present. For example, a set of three lights may beprovided to indicate three levels of safety of an individual: in safetyzone, close to the border of a safety zone, and outside of safety zone.Alternatively, a set of three lights may be provided to indicate anotherthree levels of safety of an individual: sticker device is connectedwith the smart wearable the second smartphone, sticker device isdisconnected with the smart wearable the second smartphone but is withina defined safety zone, and sticker device is disconnected and outside ofa defined safety zone. The foregoing is merely exemplary and it will beunderstood that the level of safe zones may be further divided to four,five, six, seven, eight, nine, ten or more levels. In anotherembodiment, safe zones may be defined by a specific geographical radiusand a location. In certain embodiments, the geographical radius for asafe zone may be about 0.1, 0.2. 0.3. 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0,1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8. 1.9, or 2.0 miles. In someembodiments, the location may be pre-set into smart wearable the secondsmartphone through the cloud servers or manually set using a button ofsmart wearable the second smartphone as an individual arrives at adestination. In yet another embodiment, a safe time zone may be providedto smart wearable devices by synchronizing with an individual's calendaron a cloud server.

In some embodiments, upon losing connection with a sticker device, asimple wearable device may produce an audio alert, a vibration, or aflashing light to notify the subject of the separation from themedication container. In certain embodiments, a snooze button may beprovided to allow a subject to stop the audio alert, vibration, orflashing light for a period of time, for example, 15 minutes. In anotherembodiment, a subject may program a period of quiet time into the simplewearable device via a smart mobile device to mute the alarm for anextended period of time. In yet another embodiment, a subject mayprogram alarms to be triggered at certain times during the day via asmart mobile device, so that the subject would be reminded to check fora medication container in his or her possession.

In some embodiments, a snooze button 4006 may be provided to allow asubject to stop the smart wearable the second smartphone from vibratingfor a period of time such as, for example, 15 minutes. In yet anotherembodiment, an inquiry button 4013 may be provided to allow a subject tolisten to pre-recorded emergency instructions.

FIGS. 9, 10A, and 10B depict circuit schematics for a wearable accordingto an exemplary embodiment of the invention. In an embodiment such asFIG. 9 depicts, core logic and wireless systems 1000 may be implemented,e.g., as with the sticker 120, by a Bluetooth® SoC 1010 such as thenRF51422 or nRF51822.

FIG. 10A depicts circuit schematics for additional systems such as maybe part of an implementation of a wearable 130 according to anembodiment of the invention. As depicted, the batteries provide inputpower in connection with battery input circuit 1020 and voltageregulation circuit 1025, and they may be recharged, e.g., through theUSB-micro port 850 (FIG. 8), by a circuit 1030 (FIG. 10A) such as thedepicted one, which includes a commercially available charge managementcontroller 1035. As depicted, the USB-micro port 850 (FIG. 8) may alsobe used to program the SoC 1010 (FIG. 10).

FIG. 10A also depicts a real-time clock circuit 1040 such as may be usedin connection with an embodiment of the invention.

FIG. 10B depicts further circuits and components such as may be used toimplement a wearable 130 in connection with embodiments of theinvention. As depicted, these may include, e.g., a circuit 1050containing a three-color LED 1055; a button 1060 to activate “Find MyPen” functionality and another 1065 to activate emergency mode; a “fuelgauge” or power measurement circuit 1070; a circuit 1075 to drive avibration motor; and a circuit 1080 to drive a buzzer.

FIG. 11 depicts a home base station 150 according to an embodiment ofthe invention, showing views (a) from the front, (b) from the rear, and(c) from above. (The view of the home base station from above does notdepict a cover 1110, e.g., as described below.) The name “home basestation” reflects how this base station 150 may be designed orconfigured, according to embodiments of the invention, to be suited forinstallation, e.g., in a subject's home. It will be appreciated,however, that this name does not reflect a necessary limitation; exceptas explicitly stated otherwise, or as would necessarily be inconsistentwith the structure and functions described here, a home base station 150may be installed and/or used in any desired location.

In an embodiment such as FIG. 11 depicts, a home base station 150 may becapable of receiving and storing two autoinjectors 1120, each with asticker (not pictured) attached. To accommodate the autoinjectors 1120,the home base station 150 may have a body 1125, and the body may beshaped to include, e.g., two wells 1130, each capable of holding oneautoinjector 1120 upright.

In embodiments of the invention the body 1125 may be made, e.g., ofthermoplastic, and it may in whole or in part be opaque, translucent, ortransparent. In an embodiment, one or more light sources (such as LEDs)(not pictured) may be placed inside the body 1125 so that they may emitlight through one or more translucent or opaque regions, thereby makingthe light visible outside the home base station 150.

A cover 1110 may be provided, e.g., to enclose and/or protect theautoinjectors 1120. The cover 1110 may be wholly or partly transparentand/or translucent, as FIG. 11 depicts, thereby providing a way todetermine whether either or both autoinjectors 1120 are in place withoutremoving the cover 1110. In an embodiment of the invention, one or moreswitches (not pictured) may be placed and configured to detect whetherthe cover is in place and generate an electrical signal indicating thisstate.

In an embodiment such as FIG. 11 depicts, a home base station 150 mayinclude, e.g., on the front, a button strip 1140, which may include,e.g., an emergency button 1145, a cancel button 1150, and a “find mypen” button 1155. On the back, a home base station 150 as depicted mayinclude a jack 1160 through which power may be supplied, e.g., from awall outlet adapter or other source. It may also in an embodimentinclude a USB jack 1165 that is configured to supply power for charginga device, such as, e.g., a wearable (not pictured).

A home base station 150 in an embodiment of the invention may beconfigured to be capable of displaying information, e.g., by providing aflat, recessed area 1170 with a clear plastic protective cover 1175 thatleaves an opening at the top of the recessed area 1170. Information suchas instructions for using the device and/or responding to apparentanaphylaxis may be printed, e.g., on a card (not pictured) and placed inthe recessed area 1170, behind the protective cover 1175. The home basestation 150 may be configured so that the contents of the recessed area1170 may easily be removed and replaced, and in an embodiment, the cardmay carry information on both sides, or a booklet (not pictured) may beprovided for storage in the recessed area 1170.

In an embodiment of the invention, a home base station 150 may becapable of detecting whether either or both wells 1130 contains, e.g.,an autoinjector. For example, the presence or absence of an autoinjectoror other object may be detected through a mechanical switch (notpictured), e.g., in the wall of the well 1130 or at the bottom of it.The presence or absence of an electrical signal in a circuitcorresponding to a well 1130 may indicate to other components in anembodiment the presence or absence of an autoinjector (or the converse).

FIG. 11 depicts a home base station 150 designed to be used withautoinjectors 1125, e.g., for epinephrine. It will be appreciated that ahome base station 150 in embodiments of the invention may be configuredto receive and store other types of medication containers and/or othertypes of objects (not pictured); in such embodiments, the shape ofeither or both wells 1125 may vary, e.g., to correspond to the containeror object (or part thereof) that the well 1125 is meant to hold. Inother embodiments of the invention, one or more of the wells 1125 may bereplaced by other means of holding an object, including (but not limitedto) hooks, shelves, and or magnets, among many other possibilities.

Further, a home base station 150 according to embodiments of theinvention need not be configured to hold up to two objects, but it maybe configured, e.g., to receive and store any desired number of objects.It may further be configured to receive and store multiple types ofobjects, e.g., by including one or more wells 1125 and/or other meanscapable of holding more than one kind of object in a particular spaceand/or by having multiple spaces, each configured to receive and storeone or more different kinds of objects.

FIGS. 12, 13, 14, 15, and 15A depict circuit schematics for a home basestation 150 according to an embodiment of the invention. As with thesticker 120 and wearable 130 discussed previously, core logic andBluetooth®-related wireless systems 1200 may be implemented with aBluetooth® SoC 1210 such as the nRF51422 or nRF51822. In an embodimentof the invention, a separate system 1220 may implement Wi-Fi®, e.g., asFIG. 13 depicts, using a separate microcontroller 1225 such as theCC3200MOD, commercially produced by Texas Instruments™.

FIG. 14 depicts systems for generating and outputting sound according toembodiments of the invention. In an embodiment such as FIG. 14 depicts,a system 1230 containing, e.g., a VS1000 Ogg Vorbis Player Systemcircuit 1232, which may generate audio for playback, and the audio maybe supplied, e.g., to an amplifier circuit 1235 to drive a componentsuch as a speaker (not pictured), for example, for playback. A storagecircuit 1240, e.g., as depicted, may include a serial flash circuit 1243that stores digitized audio for playback.

FIG. 15 depicts circuits for accepting input, e.g., from switches and/orbuttons, and for driving RGB LEDs for visual output, according toembodiments of the invention. FIG. 15A depicts further support circuits,according to an embodiment of the invention, for receiving and supplyingpower 1260, 1265, for programming and debugging 1270, 1275 theBluetooth® 1210 and/or Wi-Fi® 1225 microcontrollers, and for loadingaudio files 1280 to the decoder 1232.

As discussed in this disclosure, a home base station 150 according toembodiments of this invention may, e.g., determine a location of one ormore other devices, including, e.g., one or more stickers and/orwearables. It may in some cases be desirable to have a device in alocation that may perform these functions without necessarily being ableto store any autoinjectors. Thus, in an embodiment of the invention, avirtual checkpoint device may be provided. In embodiments, the virtualcheckpoint device may be simply a home base station that has beenmodified to remove its storage capacity.

Alternatively, in embodiments of the invention, a virtual checkpointdevice may comprise, e.g., a communication module and an alarmconfigured to be triggered upon a determination that a wearable ispresent without a sticker device. The alarm may be an audible alert, atactile alert, or a visual alert. As with a home base station, a virtualcheckpoint device may determine its location, e.g., via GPS or otherdirect means and/or via IP-based geolocation. In some embodiments, avirtual check point device may be installed near a door of a subject'shouse, near a school bus door, near the gate of a school, a daycarefacility, or a camp. In embodiments, a virtual checkpoint device may bepowered, e.g., by AC mains, directly or via a separate power adapter,and in embodiments, a virtual checkpoint device may be powered by one ormore rechargeable and/or non-rechargeable batteries.

FIG. 16 depicts a public base station 160 according to embodiments ofthe invention. As depicted, the public base station 160 includes a body1605 and a cover 1610, which may be connected to the body 1605, e.g., byone or more hinges (not pictured), such that the cover may be opened bylifting it. The cover 1610 may be made, e.g., of transparent plastic todisplay the public base station's contents while protecting them. In anembodiment of the invention, one or more switches (not pictured) may beplaced and configured to detect whether the cover is in place andgenerate an electrical signal indicating this state.

In embodiments of the invention, the body 1605 may be made, e.g., ofopaque or translucent thermoplastic or other material. In an embodimentof the invention, some or all of the upper surface 1615 of the body maybe translucent, e.g., to allow indicator lights contained within thepublic base station 160 to be seen on the outside.

In several ways, a public base station 160 according to embodiments ofthe invention may resemble, e.g., a home base station 150 as describedabove. For example, as depicted, the public base station 160 includestwo wells 1620 or other receptacles, each configured to hold a singleautoinjector 1625 with a sticker (not pictured) attached. It will beappreciated that a public base station 160 in embodiments of theinvention may be configured to receive and store other types ofmedication containers and/or other types of objects (not pictured); insuch embodiments, the shape of either or both wells 1620 may vary, e.g.,to correspond to the container or object (or part thereof) that the well1620 is meant to hold. In other embodiments of the invention, one ormore of the wells 1620 may be replaced by other means of holding anobject, including (but not limited to) hooks, shelves, and or magnets,among many other possibilities.

Further, a public base station 160 according to embodiments of theinvention need not be configured to hold up to two objects, but it maybe configured, e.g., to receive and store any desired number of objects.It may further be configured to receive and store multiple types ofobjects, e.g., by including one or more wells 1620 and/or other meanscapable of holding more than one kind of object in a particular spaceand/or by having multiple spaces, each configured to receive and storeone or more different kinds of objects.

In an embodiment of the invention, a public base station 160 may becapable of detecting whether either or both wells 1620 contains, e.g.,an autoinjector. For example, the presence or absence of an autoinjectoror other object may be detected through a mechanical switch (notpictured), e.g., in the wall of the well 1620 or at the bottom of it.The presence or absence of an electrical signal in a circuitcorresponding to a well 1620 may indicate to other components in anembodiment the presence or absence of an autoinjector (or the converse).

Despite the differences in shape and/or function between a public basestation 160 and a home base station 150, the electronics within a publicbase station 160 according to embodiments of the invention maysubstantially resemble those of the embodiments of the home base station150 described above. The differences in operating environments andfunction between the two kinds of base stations in embodiments of theinvention, e.g., such as are described below may lead to someadaptations of the circuits to the different environments, but suchadaptations will be apparent to a person skilled in the art who isfamiliar with those functions and environments. For example, a publicbase station 160 may in an embodiment of the invention be permanentlywired to AC mains, in which case the circuitry may incorporate anAC-to-DC adapter, e.g., as is known in the art.

As FIG. 1 depicts, according to embodiments of the invention, functionsand services may be provided using, e.g., one or more interactingstickers 120, wearables 130, home base stations 150, and/or public basestations 160, which may function, e.g., as described above. Some or allfunctions, services, or both, may also be provided according toembodiments of the invention in connection with one or more userdevices, such as, e.g., smartphones with a mobile app 140. Inembodiments of the invention, one or more such devices may, e.g.,coordinate and/or administer these functions and services, which mayfurther, in embodiments of the invention, be provided in connection witha support infrastructure 170.

In some embodiments, a smart mobile phone the second smartphone maycomprise an application 130 stored in a memory module thereon. Referringto FIG. 17A, application 130 may comprise a user interface 140, which isin communication with session manager 13007, communication manager13008, content manager 13012, and Bluetooth® device manager 13014.Communication manager 13008 may further be in communication with restapplication programming interface (API) 13009 and state manager 13011.Content manager 13012 may be in communication with PNG/HTML 13013.Bluetooth® device manager 13014 may be in communication with iOS®Bluetooth® Low Energy (BLE) application programming interface (API)13015 and state manager 13011. State manager 13011 may be incommunication with data abstraction layer 13006 and user interface 140.Application 130 may further comprise core data database 13001 thatstores user profile data 13002, device data 13003, local event log13004, and allergen data 13005. Core database 13001 may be incommunication with data abstraction layer 13006, which is in turn incommunication with session manager 13007.

Functions and services according to embodiments of the invention may befurther illustrated, e.g., in connection with description of theoperation of an exemplary mobile app 140 according to an embodiment ofthe invention. Further, the description of a mobile app 140 according toan embodiment may assume or refer to certain conventions of certainoperating environments; for example, a description may assume or referto a user interface component and/or convention associated with iOS™.The description is not in any way meant to be limited by this, however,and it will be appreciated that an application in an embodiment of theinvention may exhibit the disclosed characteristics, e.g., in otheroperating environments and/or other devices and/or types of devices.Where appropriate, a user may interact with (or according to) anembodiment of the invention using a device other than a mobile device,e.g., with a person computer using a Web browser and/or other software.

The discussion of a mobile app 140 according to embodiments of theinvention may refer extensively to screens that such an app 140 maycause a mobile device to display. It will be appreciated, however, thatmany applications are intended to display more information in a singlepage or other display than conveniently may fit within the displaydevice incorporated into a mobile device, so many mobile operatingenvironments support scrolling. With this in mind, content that may betoo large to be entirely displayed on a screen at once may nonethelessbe referred to as part of a single screen if conventional scrolling maysuffice to bring different parts of that same content into view. Somedescriptions of particular screens may refer explicitly to scrolling,but the lack of such explicit reference should not be taken to mean thatscrolling does not occur, if the context reasonably requires it to.

FIG. 17 depicts examples of a home screen 1700 of a mobile app 140according to an embodiment of the invention. As depicted, the homescreen 1700 includes an image 1710 (here, a photo) representing thesubject and, superimposed on that image 1710, another image 1714representing a tracked object, here, an EpiPen® autoinjector. Asdepicted, the image 1714 is an icon that includes a symbolicrepresentation 1718 of an autoinjector, but a photo may also serve.Similarly, the image 1710 representing the subject need not be a photoof the subject and may in an embodiment be a photo of something otherthan the subject, or it may be some other image.

A home screen 1700 according to an embodiment of the invention mayinclude status information. For example, as depicted, the home screen1700 indicates a time 1722, the name of the subject 1726, and text 1730representing that, at the indicated time 1722, the subject had anEpiPen®. In an embodiment of the invention, if the mobile app 140 isinstalled on a device that belongs to the subject or is otherwisepersonally associated with subject, the subject's name 1726 may bereplaced by the word “you” (not pictured).

The depicted home screen 1700 also includes a slider 1734, labeled“Emergency”. By activating this slider 1734, the user can enteremergency mode, signifying that the subject may be having a severeallergic reaction, which may be anaphylaxis.

The home screen 1700 indicates that the subject “has” an EpiPen®. Inembodiments of the invention, this may mean that an autoinjector isknown to be reasonably accessible to the subject by some standard, asdiscussed elsewhere.

If the system cannot determine that the subject has a reasonablyaccessible autoinjector, however, the mobile app 140 may indicate this.

FIG. 18 depicts a modified home screen 1800 that includes text 1804indicating that, at the indicated time 1808, the subject does not havean autoinjector. In this circumstance, the modified home screen 1800 maydisplay additional user interface elements. For example, a button 1820labeled “Locate Pen” may be presented, which may cause the mobile app140 to attempt in various ways to locate a nearby autoinjector. Anotherbutton 1824, labeled “See History” may cause display of informationabout the subject, including, e.g., information about the subject'slocation, access to autoinjectors, and/or entry into and/or exit fromemergency mode.

According to embodiments of the invention, a home screen of a mobile app140 may present additional information that may be useful or desirablein some way. For example, FIG. 19 depicts a home screen 1900 accordingto an embodiment of the invention that, in addition to the informationdepicted in FIG. 17, also indicates 1910 the subject's location andidentifies 1914 a member of the subject's team who is at the indicatedlocation with the subject.

To enhance navigation with the mobile app 140, according an embodimentof the invention, screens—including, e.g., the home screen 1700 (FIG.17)—may include a menu button 1750. When this button 1750 is selected,the mobile app 140 may present a navigation menu 2000, e.g., as FIG. 20depicts.

As depicted, a navigation menu 2000 may identify the user, e.g., by name2004, and indicate one or more of the user's roles 2008 within thesubject's team. The navigation menu 2000 may also present, e.g., a label2012 that identifies the subject and/or team; this label 2012 may be thesubject's name, or it may include part or all of the name, but it may inan embodiment of the invention be configured to be any text that a userbelieves to be useful.

Navigation options according to an embodiment of the invention mayinclude, e.g., “Team” 2016; “Devices” 2020; “Allergy 101” 2024;“Notifications” 2028; and “Settings” 2032. In an embodiment of theinvention, the “Notifications” option 2028 may include, e.g., an alert2036, which may indicate, e.g., the number of notifications receivedand/or the number of received notifications that remain unread. Asdescribed below, each menu item may lead, e.g., to a screen presentinginformation and/or functions associated with the respective menu item.

A settings icon 2040 may also be provided. In an embodiment of theinvention, this icon may be provided, e.g., only for users who have someor all administrative privileges with regard to a team, and may enablenavigation, e.g., to a screen that presents administrative informationand/or functions to those users. Alternatively, a settings icon 2040 mayenable navigation, e.g., to a screen such as the “Settings” 2032 menuitem enables navigation to.

According to embodiments of the invention, a user may be a member of twoor more teams. Information associated with the user's membership in aparticular team may be referred to as a “profile”, and, in an embodimentof the invention, a navigation menu may include a profile switcher 2060.As depicted, a profile switcher 2060 may include an “add profile” button2070 for use, e.g., when the user wishes to join another team.

For each of the user's existing profiles, the profile switcher 2060 mayinclude a user interface element allowing the user to select one of theprofiles to activate. For example, in an embodiment such as FIG. 20depicts, the profile switcher 2060 includes an image 2074 for eachprofile; in an embodiment, this may be, e.g., the same image 1710 (FIG.17) that represents the relevant subject, although possible reduced forsize. The currently active profile may be indicated, e.g., byhighlighting the image 2078 associated with it and/or by dimming theother images 2082. A visual alert (as depicted, a red circle) 2086 mayindicate in an embodiment that a profile has one or more unreadnotifications associated with it.

According to an embodiment, the navigation menu 2000 may be dismissed,e.g., by means conventional in the operating environment. For example,using a mobile app 140 on an iPhone®, a user may dismiss the navigationmenu, e.g., by tapping on the screen in the area 2090 outside of thenavigation area.

FIG. 21 depicts a team list screen 2100 according to an embodiment ofthe invention, such as a mobile app 140 might display followingselection of “Team” 2016 (FIG. 20) from the navigation menu 2000. Thedepicted screen includes a list 2110 of members of the subject's team,and begins with a list item 2114 corresponding to the subject. The listitem 2114 comprises the subject's icon 2118 and name 2120 and a list2122 of the subject's allergies.

Below the subject's list item 2114, the list 2110 includes additionallist items 2126 for each member of the subject's team. In an embodimentsuch as FIG. 21 depicts, each additional list item 2126 includes a name2130 and a list 2134 of the member's roles. The roles may include, e.g.,one or more of “Admin”, “Parent”, and “Caregiver”, and/or others,depending on the embodiment.

A person who has been invited to join a subject's team, but has not yetdone so, may have a list item 2140. In an embodiment such as FIG. 21depicts, such a person's list item 2140 may have the words, e.g.,“Pending invitation” 2144, in place of the person's roles.

Embodiments of the invention may support messaging, e.g., as describedelsewhere. In such embodiments, a list item 2126 may include, e.g., anicon 2150 that, when selected, initiates a text messaging sessionbetween the user and the selected team member. In an embodiment, textmessaging may proceed, e.g., via a user interface and/or facilities suchas may be familiar in the art. A list item 2154 may allow initiation ofa voice conversation with the selected team member, e.g., as a cellulartelephone call or otherwise.

Similar icons for text and/or voice communication (not pictured) mayappear in the list item 2114 for the subject in embodiments of theinvention. It will be appreciated, however, that a team list screen 2100such as FIG. 21 depicts may be presented specifically to the subject,and therefore the communication icons may be included in only list items2126 corresponding to other users. Conversely, in a team list screen2100 presented to a user other than the subject, the icons 2150, 2154may be absent from that's users own list item 2126 but present in thesubject's list item 2114.

In an embodiment of the invention, a team list screen 2100 presented toan administrative user may include one or more elements allowingperformance of administrative tasks. For example, as FIG. 21 depicts,the team list screen 2100 includes a button 2160 labeled “Manage”. Whenselected, this button may modify the list to include controls (notpictured) that allow the user, e.g., to delete team members and/or tomodify their roles and/or privileges.

An administrative user may in an embodiment of the invention also bepresented with a control 2170 that allows the user to add a team member.When selected, the mobile app 140 may present, e.g., an add team memberscreen 2200, as FIG. 22 depicts. As depicted, an add team member screen2200 according to an embodiment of the invention may include a form thatincludes, e.g., fields for the invitee's first name 2210, last name2214, and telephone number 2218. The form may comprise a drop-down 2222for selecting the invitee's country and another 2226 for assigning theinvitee one or more roles, which may or may not, depending on theembodiment, include the administrative role.

The form may be submitted by selecting, e.g., a button 2230 labeled“Invite”, as depicted. In an embodiment of the invention, submittingthis form may cause, e.g., a text message including a hyperlink (notpictured) to be sent to the invitee. When selecting the hyperlink, abrowser may open on the invitee's device, and the invitee may then havethe opportunity to accept the invitation and join the subject's team.

Returning to FIG. 21, a list item 2126 may enable navigation to aprofile for the team member associated with the list item 2126. Forexample, FIG. 23 depicts a profile screen 2300 according to anembodiment of the invention. As depicted, the profile screen 2300includes the team member's name 2310 and user picture 2314. The depictedprofile screen 2300 also includes the team member's full name 2318. Alsoas depicted, the profile screen 2300 may include the team member'scontact information; for example, it may include the team member's emailaddress 2330 and telephone number 2334.

Team members may be able to edit their own profiles. For example, asFIG. 23 depicts, a button labeled “Edit” 2340 may be provided, andselecting it may cause the mobile app to present one or more screens(not pictured) that allow the user to edit the profile. In embodiments,the Edit button 2340 may be absent when viewing other team members'profiles.

As depicted, the profile screen 2300 presents an icon 2350 that, whenselected, may dismiss the profile screen 2300 and return the user, e.g.,to the team member list screen 2100 or other screen.

FIG. 24 depicts a subject's profile screen 2400 according to anembodiment of the invention. Much of the information is the same as thatpresented on a team member's profile screen 2300 (FIG. 23), although inthe view that FIG. 24 depicts, some of the similar information has beenscrolled out of view to make room for other items. The subject's profilescreen 2400, in an embodiment of the invention such as FIG. 24 depicts,may also include information relevant to the subject's allergy (notpictured) and/or one or more tools for navigating to such information.

For example, as depicted, the subject's profile screen 2400 includes asummary list 2410 of the subject's allergies that, when selected, maylead to a display of additional information about those allergies (notpictured). The profile screen 2400 may also include a tool 2420 leadingto instructions (not pictured) on what to do if the subject is having anallergic reaction and/or a tool 2430 leading to a display (not pictured)of team members and/or others to be contacted in case of an allergicemergency.

The subject's profile screen 2400, in an embodiment such as FIG. 24depicts, may include a button or other control 2440 labeled “ShareProfile”. When selected, this may cause, e.g., the mobile app to sharethe user's profile, e.g., with one or more other users, either directlyor via support infrastructure.

The navigation menu 2000 (FIG. 20) in an embodiment of the inventionincludes a “Devices” 2020 menu item. In an embodiment of the invention,selection of that item may cause a mobile app 140 to present, e.g., adevices list screen 2500 such as FIG. 25 depicts. As depicted, thedevices list screen 2500 includes a list 2510 of entries 2514 fordevices (e.g., stickers 120 and wearables 130) that have been associatedwith the subject (named “Alison”). (Note that in the followingdiscussion, for brevity, reference may be made to an autoinjector thatis associated with the subject; unless explicitly stated otherwise, theassociation may be in a strict sense between the subject and a sticker120 that is affixed to the autoinjector.)

The list of devices 2510, as FIG. 25 depicts, includes two visibleentries 2514 for devices, although more than two devices may commonly beassociated with a single subject, and it may be assumed that entries foradditional devices may be brought into view, e.g., by scrolling thedisplayed part of the list 2510 down.

As depicted, one entry 2518 corresponds to an Auvi-Q® epinephrineautoinjector. This entry 2518 includes an image 2522 that represents theautoinjector and, superimposed on it, a small version 2526 of thesubject's user picture. The entry also includes a name 2530 associatedwith the autoinjector (here, “On-the-go Auvi Q”) and the estimated oractual time remaining 2534 until the autoinjector will reach themanufacturer's expiration date. In an embodiment of the invention,selecting the entry 2518 (e.g., by tapping on the image 2522 thatrepresents the autoinjector) will cause the mobile app 140 to presentadditional details about the autoinjector.

As FIG. 25 depicts, the autoinjector's location is known, at least inthat the autoinjector is known to be sufficiently close to the subjectto be considered “with” her, and the entry 2518 indicates that status2538. In embodiments of the invention, if the location of theautoinjector were not known, or if it were known to be separated fromthe subject, the entry 2518 would indicate that status (not pictured)instead.

The depicted entry 2518 includes an arrow-shaped icon 2542 that whenselected, in an embodiment of the invention, causes the mobile app 140to display a map view that indicates the location of autoinjector, ifknown, and may additionally indicate locations of one or more otherdevices, including e.g., other autoinjectors, wearables, and/or basestations, among other possibilities. Another icon 2546, when selected,will attempt to put the autoinjector into “Find My Pen” mode, e.g., asdescribed elsewhere.

The second visible entry 2555 in the list 2510 corresponds to a wearablethat is associated with the subject, Allison. As with the autoinjector,the entry 2555 for the wearable includes an image 2560 that representsthe wearable and a name 2564 associated with the wearable (here,“Allison's Wearable”). In an embodiment of the invention, selecting theentry 2555 (e.g., by tapping on the image 2560 that represents thewearable) will cause the mobile app 140 to present additional detailsabout the wearable.

The depicted entry 2555 includes a battery strength indicator 2568: asdepicted, the wearable's battery is reported to be at 80% of a fullcharge.

As FIG. 25 depicts, the wearable's location is known, at least in thatthe wearable is known to be sufficiently close to the subject to beconsidered “with” her, and the entry 2555 indicates that status 2572. Inembodiments of the invention, if the location of the autoinjector werenot known, or if it were known to be separated from the subject, theentry 2572 would indicate that status (not pictured) instead.Alternatively, in an embodiment of the invention, the location of thewearable could be used as a marker of the subject's location; in such anembodiment, the meaning of the status 2572 that the wearable is “withAllison” might be that Allison, the subject, is assumed to be with thewearable, and proximity to the wearable may be treated as an indicationof proximity to Allison.

The depicted entry 2555 includes an arrow-shaped icon 2576 that whenselected, in an embodiment of the invention, causes the mobile app 140to display a map view that indicates the location of wearable, if known,and may additionally indicate locations of one or more other devices,including e.g., other autoinjectors, wearables, and/or base stations,among other possibilities. Another icon 2580, when selected, willattempt to put into “Find My Pen” mode all stickers, associated with thesubject, that receive the local signal, e.g., as described elsewhere.

In an embodiment of the invention, another type of entry (not pictured)may correspond, e.g., to home base stations that may be associated withthe subject. The information that such an entry presents and/or thefunctions provided by this type of entry may resemble, e.g., the entry2518 for an autoinjector and/or the entry 2555 for a wearable, possiblymodified, e.g., to include information specific to a base station, suchas whether the base station includes one or more useable autoinjectors.

In an embodiment of the invention, the devices list screen 2500 mayinclude an Add Device button 2590, e.g., as FIG. 25 depicts. When theuser selects this button, the mobile app 140 may respond, e.g., with anew device selection screen 2600, e.g., as FIG. 26 depicts. In anembodiment, the user may select the kind of device to be added.

If the user chooses to add a new sticker, e.g., by tapping “Sticker”2610 on the new device selection screen 2600, the mobile app 140 in anembodiment of the invention may begin a flow 2700 such as FIG. 27depicts.

The flow, according to an embodiment such as FIG. 27 depicts, may beginat block 2710, in which a user holds down the pair/cancel button on asticker for a predetermined time, typically 3-5 seconds. After this, thesticker may enter 2720 pairing mode and may so indicate, e.g., bycausing a blue LED to flash and/or by emitting one or more sounds.

The mobile app 140 may direct the user to place the sticker next to themobile device on which the app 140 is running and may activate thesticker in block 2730. Activating the sticker 2730 may vary depending onthe embodiment and the technological environment, but it may include,e.g., pairing the mobile device with the sticker, setting one or morevalues in persistent memory within the sticker, and/or transmittinginformation, e.g., associating the sticker with the subject, to supportinfrastructure. If activation is successful, the mobile app may indicatethis fact, e.g., in block 2740.

Once the sticker has been activated, the mobile app 140 may prompt theuser to configure the device in block 2750, e.g., by displaying asticker configuration screen 2800 such as FIG. 28 depicts. The requestedinformation may vary depending on the embodiment, but as FIG. 28depicts, the user may be asked to give the sticker a name 2810, whichmay describe the object that the sticker is affixed to (e.g., “Allison'sHome Pen”). The user may also select the type of object, e.g., from adrop-down 2820 and enter an expiration date for the medication or itscontainer 2830. When the user is satisfied with the configuration data,the user may select the “Done” button 2840.

In response, the mobile app 140 may in block 2760 (FIG. 27) store someor all of the configuration data locally and/or send some or all of theconfiguration data to the support infrastructure and/or the configuredsticker. In an embodiment, this configuration can also include, e.g.,setting the BLE UUID, although this may in an alternative embodimentoccur instead at the time of pairing, e.g., in block 2730. The mobileapp 140 may then in an embodiment return to displaying, e.g., a deviceslist screen 2500 (FIG. 25), which may now include the newly-addedsticker.

From the new device selection screen 2600 (FIG. 26), the user may in anembodiment of the invention select “Wearable” 2620. This selection maylead to a flow (not pictured) for adding a wearable, which may inembodiments of the invention resemble the flow 2700 (FIG. 27) for addinga sticker, possibly with modification reflecting differences betweenstickers and wearables.

Adding a wearable in this way may in embodiments cause the wearable tobe considered part of the subject's network, which may in turn lead tosynchronization of information, e.g., the wearable, the smartphone, andthe support infrastructure. For example, in an embodiment of theinvention, data may be shared such that: 1) the wearable is made awareof what stickers it should be observing; 2) the wearable is made awareof quiet times, viz., periods in which it ought not signal a failure todetect stickers; and 3) a log of observations of stickers and loss ofstickers over time is sent to the smartphone and server. In embodimentsof the invention, changes to any or all of the shared data may propagatefrom device to device, e.g., when a smartphone or base stationcommunicates with a wearable.

From the new device selection screen 2600 (FIG. 26), the user may in anembodiment of the invention choose to add a new home base station, e.g.,by tapping “Base Station” 2630. In response, the mobile app 140 in anembodiment of the invention may begin a flow 2900 such as FIG. 29depicts.

As depicted, the flow 2900 begins in block 2910 with the mobile appdirecting the user to supply power to the base station, e.g., byplugging it in, and to gather certain information that may be neededduring setup, such as, e.g., the SSID and password for a Wi-Fi® networkthat the base station will join during setup. In block 2920, the mobileapp may prompt the user for the SSID and password, which the user maythen enter.

In block 2930, the mobile app connects to the base station, e.g., via anad hoc wireless network, and then in block 2940, the mobile apptransmits the SSID and wireless password to the base station. In block2950, the base station uses this information to connect to thedesignated network.

According to an embodiment of the invention, once the base station hasconnected to the Wi-Fi® network, the base station may then be paired tothe phone and/or mobile app, e.g., as block 2960 represents. The usermay pair the devices, e.g., by holding down a cancel/pair button on thebase station (e.g., as discussed above) for a predetermined time, e.g.,3-5 seconds. One or more LEDs within the base station may glow, e.g.,blue, to indicate that the base station is in pairing mode, and thenpairing may be completed, e.g., from the mobile app or a facilityprovided by the mobile device's operating environment.

One consequence of pairing the mobile app with the base station,according to an embodiment of the invention, may be to associate thebase station with the subject, and information indicating thisassociation may be sent to the support infrastructure, e.g., at the timeof pairing or, later, when other information about the base station'sconfiguration is sent to the support infrastructure.

Once the mobile app has been paired with the base station, the user maythen in an embodiment further configure the base station. For example,the mobile app may prompt the user for a name for the base station. Inan embodiment of the invention, the user may be prompted for informationthat specifies the location of the base station, e.g., when the locationis not determined via GPS, IP-based geolocation, or other automaticmeans. Block 2970 represents the user's entry of this information.

In block 2980, the mobile app transmits the configuration information tothe base station with which it has just been paired. The base stationmay store this information, e.g., in persistent memory. Further, in anembodiment of the invention, information identifying the base stationand describing its configuration may be sent, e.g., to the supportinfrastructure for future reference.

In certain embodiments, a smart base station device 50 may connect witha cloud server to obtain identification of all the devices registeredwithin a medication system management system, e.g., as here described.Upon receipt of the identification of the registered devices, smart basestation device 50 may establish a connection with those devices oncethey are present within a region of detection.

As FIG. 25 depicts, a devices list screen 2500 may in an embodiment ofthe invention include a button or other control 2595, e.g., labeled“Manage Devices”. Selecting this button may, e.g., cause display of oneor more controls (not pictured) allowing the user to remove one or moredevices, e.g., individually, and/or change configuration information forany one or more devices.

Returning to FIG. 20, the navigation menu 2000 may include an item 2024labeled, e.g., “Allergy 101”. Selection of this item may in anembodiment of the invention cause the mobile app to present educationalinformation (not pictured) related, e.g., to severe food allergies. Theeducational information may cover any one or more of a wide variety oftopics, including (among many possibilities) food allergies generally,the particular food allergies that affect the subject, techniques foravoiding allergens, ways to detect anaphylaxis, and how to respond toanaphylaxis if it should be suspected or actually in progress. Theeducational information may be in any one or more of multiple forms,which may include, e.g., text, still and moving pictures, and audio.Educational information may be stored locally, e.g., within the mobileapp, and/or accessed remotely, e.g., via the Internet and accessed viaone or more hyperlinks presented by the mobile app.

The navigation menu 2000 in an embodiment of the invention may includean item 2028 allowing the user to see any notifications provided by thesystem. The presentation of the notifications may vary, e.g., with theoperating environment and/or the embodiment of the invention, but maytake the form, e.g., of a list (not pictured) of entries, one for eachnotification. The user may in such an embodiment select a notification'sentry, and the mobile app may respond, e.g., with the details of thenotification (not pictured).

In embodiments of the invention, support infrastructure may exist thatsupports and coordinates the functioning of other components, bothindividually and in combination with each other. In an embodiment, thesupport infrastructure may be one or more computer servers, and thesupport infrastructure may thus be referred to as the “server”.

For example, in an embodiment of the invention, a server acting as thesupport infrastructure may be a computer system including, e.g., one ormore computers operating the Ubuntu® platform based on the Linux®operating system. A Ubuntu® host server may comprise, e.g., an Nginx®server and rails server application. A Ubuntu® host server may furthercomprise a PostgresDB that acts as the data tier for the from railsserver application. A rails server application may further communicate,e.g., with an Amazon® Simple Notification Service (SNS) server and/or aTwilio® call gateway. The Amazon® SNS server may in turn communicatewith Apple® Push Notification Service (APNS), which may provide pushnotifications to a mobile device. The Twilio® call gateway may providevoice or short messaging service (SMS) transmission a mobile device.

In some embodiments, the sticker 120, wearable 130, and home basestation 150 may provide BLE transmission to a mobile app 140 on a mobiledevice. In further embodiments, a mobile device may provide cellular orother data transmission to the server via a REST application programminginterface (API). Similarly, in an embodiment, home base station 150 mayuse Wi-Fi® to connect to the Internet and interact with the server via aREST API. In some embodiments, the REST API serves as a front end on theserver, through which other devices and applications communicate withthe rails server application.

In embodiments of the invention, the support infrastructure may receiveand correlate information from many devices, e.g., as disclosed above,to determine whether a subject has sufficient access to an autoinjectorand to generate alerts if a subject appears not to have such access.Individual devices may similarly generate and/or transmit alerts, e.g.,if they cannot receive a signal from an appropriate device.

It will be appreciated that the architecture of a support infrastructuredescribed above is only one possible implementation. According toembodiments of the invention, other architectures are possible,including, e.g., architectures within which multiple machines performtasks described as being performed by a single machine and/or viceversa. It will further be appreciated that such a support infrastructuremay be implemented on a cloud-based computer platform, e.g., as may beknown in the art and commercially available.

In embodiments of the invention, a support infrastructure may recorddata including configuration data, profiles, history, and any otherinformation related to the operating of the system that it may bethought desirable to store. It will be appreciated, however, that thismay, in embodiments of the invention, allow any device or devices to bereplaced as necessary, with any relevant information being restored tothe replacement device, e.g., from the support infrastructure.

In an embodiment, alert (or, equivalently in this context, notification)technology may use a passive system to look for devices; the system is“passive” in the sense that an observer—e.g., a smartphone orwearable—wakes from a lower power state as a result of a trigger eventand tries as a result to observe nearby stickers. Table 2 describespossible trigger events in an exemplary embodiment of the invention.

TABLE 2 Notification Trigger Events Trigger Event Description Initialstate An observer will scan for devices when it is activated.Significant location The observer's location (e.g., latitude andlongitude) change has changed to an extent that causes the observer tobe notified of the change. For example, an app on an iOS ™ device mayrequest that the operating environment notify the app when asystem-defined (defined by the system, not the app) has been detected.Enter region The observer has entered iBeacon range of a sticker orwearable. Exit region The observer is no longer within iBeacon range ofa sticker or wearable.

In an embodiment of the invention, each trigger event results in a scan.After an observer scans for a sticker, in an embodiment, the observermay automatically send a report of the scan and its results to thesupport infrastructure, e.g., immediately or when the opportunityarises, as described further in connection with logging.

The report may result in an immediate update to the state of the system.Table 3 lists states according to an exemplary embodiment of theinvention.

TABLE 3 System States State Meaning Subject is not with The subject'ssmartphone, as an observer, did not sticker detect a signal from thesubject's sticker. Subject is with The subject's smartphone, as anobserver, wearable but not detected a signal from the subject's wearablesticker but did not detect a signal from the subject's sticker. Subjectis with sticker The subject's smartphone, as an observer, detected asignal from the subject's sticker. Wearable is with The subject'ssmartphone, as an observer, detected sticker a signal from the subject'swearable and the subject's sticker.

It will be appreciated that wireless networking technology may makeconnections that, e.g., may frequently be broken and then reconnected.Simply generating an alert every time a connection experiences a breakmay result in many false alerts, which may be inconvenient and annoying.Other possible shortcomings of a naïve scheme for notification mayinclude, e.g., generating multiple alerts when a subject repeatedly in ashort time leaves and enters a device's iBeacon region, or when after anExit region event, a device can still be detected by a scan even thoughit remains outside the iBeacon region.

Thus, it may be desirable in an embodiment of the invention to reducethe sensitivity of (or “dampen”) some or all alerting mechanisms toreduce false or otherwise unnecessary alerts. According to embodimentsof the inventions, one or more algorithmic forms of alert dampening maybe provided, which may rely, e.g., on one or more heuristics. Forexample, in an embodiment of the invention, four distinct types ofdampening may apply: system dampening, wearable and base stationdampening, safe zone dampening, and quiet time dampening.

System dampening may refer, e.g., to dampening applied by the supportinfrastructure. In an exemplary embodiment of the invention, all triggerevents cause the triggered device to scan. (For this purpose, in thisembodiment, a “scan” may mean that a device, such as a smartphone orwearable, acts in a Bluetooth® master mode, looking for devices such asstickers.) In such an embodiment, the system state, maintained, e.g., bythe support infrastructure, may be updated immediately to reflect theresult of the scan. But the system may then wait for a timeout period(typically 1-5 minutes, depending, e.g., on the embodiment and possiblythe type of change to the system state) before broadcasting anotification from the support infrastructure (a “system notification”).In an embodiment of the invention, this timeout may be set to 5 minutes,but, in other embodiments, any value may be used, including, e.g., 30seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 6 minutes, or anyother value that is determined to be suitable.

It will be appreciated that using the support infrastructure to measuretimeout periods in an embodiment of the invention may reduce the amountof time that battery-powered devices spend in an active mode, which mayreduce the drains on their batteries. It will further be appreciatedthat the devices making up the support infrastructure may draw power,e.g., from AC mains, which would mean that battery drain may not be aconsideration for those devices.

Wearable and base station dampening may apply, e.g., to localnotifications generated from these devices. Wearables and/or basestations may in an embodiment of the invention use—and possibly remainin—a higher power mode in which they often (or effectively continuously)scan for stickers (and wearables in the case of the base station) intheir immediate area. But such a configuration may generate “noise”,though, such as may result, e.g., when a sticker is observed, then notobserved, then observed again in short order. This may happen when theobserver does not reliably receive the sticker's signal because of,e.g., RF noise, distance, or a weak signal or battery.

In embodiments of the invention, wearables may issue a localnotification when no sticker is detected, but they, too, may apply atimeout before doing so. In an embodiment of the invention, this timeoutmay be set to 3 minutes, but, in other embodiments, any value may beused, including, e.g., 30 seconds, 1 minute, 2 minutes, 3 minutes, 4minutes, 6 minutes, or any other value that is determined to besuitable.

In embodiments of the invention, a base station may similarly issuelocal notifications and similarly apply a timeout before doing so.

Alternatively, in embodiments of the invention, a base station maymerely report the observation of stickers and wearables nearby. In suchan embodiment, the base station may maintain an simple inventory ofdetected devices and immediately report any change to that inventory tothe support infrastructure. In such an embodiment, the supportinfrastructure may immediately change the system state, and systemnotification (with system dampening) may be used.

Safe zone dampening, in embodiments of the invention, refers todefinition of, e.g., geographic safe zones. If a subject is deemed to bein a safe zone, the system state may be updated continuously, e.g., asabove, but some or all notifications may be suppressed.

Safe zone dampening according to an embodiment may apply, e.g., inlocations such as a home, office, or school, in which an observer andstickers may enter and/or exit frequently, due to the movement of thesedevices in relatively close proximity to a device but nonetheless farenough away to cause frequent scanning from Enter region and Exit regionsignals.

In such an embodiment, all events sent to the support infrastructure,including, e.g., observation events of stickers or an observer no longerseeing a sticker, may cause an immediate system state update. All eventnotifications may also have location information appended, e.g., in theform of latitude/longitude or otherwise. Where an event is generated bya device with GPS capabilities, the location information may beprovided, e.g., by that device; otherwise, the location may beretrieved, e.g., from a database after having previously beendetermined, or may be determined, e.g., from IP-based geolocation orotherwise. If an event such as an observer's not finding a stickeroccurs in a safe zone, in an embodiment of the invention, the systemnotification may be suppressed.

It will be appreciated, however, that information about the subject'slocation may not always be complete. For example, a child may carry onlya wearable and an autoinjector with an attached sticker, neither ofwhich may in an embodiment include GPS or non-local communicationcapability. Moreover, the relevance of a safe zone is that, in anembodiment, it may represent a region in which the child is consideredsafe, so that the system need not rely on reports, e.g., by a basestation, that the wearable and a sticker have been observed together; byhypothesis, this may mean that no base station or other device is placedto transmit location information related to the subject.

One way to address such circumstances, according to an embodiment of theinvention, may be to consider the last known location of the wearable asits location for this purpose. For example, after a child is dropped offat school, the location may be considered to be the school, based, e.g.,on location information provided by a smartphone belonging to thesubject's parent or by a base station or other device at the school. Thesystem may consider this to be the subject's location until it receiveslocation information to the contrary, e.g., from a smartphone or basestation detecting the wearable at another location. Then, if the schoolhas been designated a safe zone, the system may suppress notificationsbased, e.g., on a failure to detect the wearable and a sticker together.

In an embodiment of the invention, the system may not suppress allalerts merely because the subject is deemed to be in a safe zone. Forexample, if required, the student may in an embodiment be alerted on awearable if no sticker is nearby, even in a safe zone.

Safe zones may be designated, e.g., using an appropriate interface (notpictured) on a mobile app and/or web application. For example, a safezone may be defined on a map view in terms of a marker (e.g., a “pin”)and a radius around that pin. The radius may in embodiments of theinvention be any value considered to be appropriate, which may typicallybe in a range of 50-500 meters, and, in an embodiment, the radius may bespecified by the user when the safe zone is define and may subsequentlybe modified. In addition to or instead of the foregoing, it may bepossible in an embodiment to define a safe zone in terms of one or moredevices, e.g., base stations.

Quiet time dampening may in an embodiment of the invention involve setupby a user of one or more time periods when system notifications may besuppressed. For example, a user may define weekdays between 8 A.M. and 3P.M as quiet times on the assumption that a child subject will be inschool during those hours and therefore supervised by caregivers,including, e.g., a school nurse. Or a user may define 10 P.M. to 6 A.M.every day as a quiet time, assuming the subject to be home in bedbetween those hours.

As discussed elsewhere, it may in an embodiment be possible to define ateam of persons to receive notifications under various circumstances.Quiet times may in an embodiment be defined with regard to particularteam members.

In embodiments of the invention, one or more protocols that may beuseful to implementing one or more devices and/or systems may notprecisely support an application such as an embodiment of the inventionmay include. For example, iBeacon™ and/or software associated with itmay not supply convenient access to an iBeacon™ major and minor ID. Foranother example, interference and/or fluctuations in system processesmay mean generation of spurious Enter region and Exit region events inthe absence of any significant movement of any device.

In an embodiment of the invention, trigger events may be based, e.g., ona combination of iBeacon™, to determine a possible trigger of activity,then an actual scan by a BLE central device to determine exact devicesin the proximity of the smartphone. The combination of the twoapproaches may realize much of the power saving attributable to BLEwhile making trigger events more reliably dependent on externalcircumstances.

In embodiments of the invention, it may be possible to configure some orany devices such that any events, or any desired subset of them, may belogged, e.g., by a support infrastructure. “Events” for this purpose canbe considered broadly to include any detectable change of state of anydevice, although it more commonly may include only such changes as,e.g., acquisition of one device's signal by another, loss of such asignal, activation and/or cancellation of an emergency, addition and/orremoval of any one or more devices, activation of “Find My Pen” status,configuration changes, powering devices off or on, and/or other changesof comparable import and/or diagnostic usefulness.

In embodiments of the invention, devices that may not enjoy continuouscontact with a support infrastructure may store log data locally untilan opportunity arises to transmit it, e.g., to a support infrastructure.For example, a wearable may maintain a record of events that involve it;when a communication channel becomes available, e.g., via a smartphone,the wearable may then transmit to a support infrastructure events thathave been recorded since the last transmission opportunity. It will beappreciated that the transmission may be direct, in the sense that thesmartphone may act essentially as a router enabling a connection betweenthe wearable and the support infrastructure, or indirect, in the sensethat the wearable may dump a record of events to the smartphone, whichmay store them and then separately transmit events from one or moredevices to the support infrastructure. It will further be appreciatedthat a device such as a smartphone may maintain its own log of eventsand may, even when functioning essentially as a router, as above, makeits own copies of the events that are passing through it on their way tobeing recorded by the support infrastructure.

It will be appreciated, however, that the result may be generation andstorage of a great deal of data about the devices and/or the actions ofthose who carry and/or use them. In embodiments of the invention, one ormore tools may exist, e.g., to analyze and/or present logged data. Forexample, within the system: 1) family and parents may be given a generalgraph of adherence during the day, possibly highlighting opportunitiesto improve adherence; 2) adherence may be scored over a generalpopulation to determine risk factors of a specific child, especially inaccordance with other medical information; general times of data andpatterns of adherence may be scored; and 4) identification, e.g., viaapplication of machine learning techniques, of events and/or cycles(e.g., weekends vs. weekdays) that may cause or exhibit varying patternsof adherence, possibly with an eye to adjustment of notification goals.

As discussed previously, devices such as stickers, wearables, and basestations may in embodiments have an emergency mode (which may also bereferred to as an emergency state). In this state, the device may act,e.g., to attract attention, possibly alerting others who may help thesubject. For example, a device may, e.g., flash lights in one or morecolors and/or make one or more sounds such as buzzing or tones.

In an embodiment, some or all devices may be configured to playback,e.g., voice instructions for how to handle the emergency. Further, in anembodiment, the instructions may prompt the user to provide input, e.g.,through one or more of a device's buttons, to control the flow of theinstructions. In an embodiment, instructions may be available inmultiple languages; a default language may be chosen, e.g., when thedevice is activated, but a user may be able to change the language inresponse to one or more prompts.

A device in emergency mode may also broadcast its status locally, e.g.,using BLE. In an embodiment, one or more devices that detect anotherdevice signaling an emergency state may themselves enter emergency mode.Alternatively, in an embodiment, a sticker detecting a nearby device inemergency mode may enter, e.g., “Find My Pen” mode, to make the pen (orother object) easier to find. Similarly, when a device receives input(e.g., from one of its buttons) to cancel an alert, in an embodiment ofthe invention, the device may broadcast this change of state locally,and other devices that detect this change of state may respond byleaving emergency mode.

An emergency may also be activated, e.g., from a mobile app on asmartphone. For example, FIG. 17 depicts a screen 1700 that includes aslide control 1734, which may be used to enter emergency state. It willbe appreciated that that a mobile app may provide one or more other waysto signal an emergency in addition to or instead of the slide control1734.

When a mobile app enters emergency state, it may broadcast this changeof state locally, e.g., with BLE. Other devices nearby, detecting thischange of state, may respond, e.g., as described above, enteringemergency mode and/or “Find My Pen” mode.

In an embodiment, the mobile app, on entering emergency mode, may walkthe user (who may not be the subject, but, e.g., a member of thesubject's team) through responding to the emergency, e.g., by taking theuser through a flow such as FIG. 30 depicts.

As depicted, the flow 3000 may begin at block 3010, with the mobile appprompting the user to confirm activation of the emergency. In anembodiment, the user may have three options. First, the user may cancelthe emergency (block 3014). Second, the user may not be sure that anemergency applies, and the app may proceed to block 3018 to help theuser determine whether anaphylaxis may be occurring.

Third, the user may confirm that, yes, the subject appears to be havingan allergic reaction. In response, the mobile app in an embodiment may,e.g., prompt the user in block 3022 to administer epinephrine using anautoinjector. The prompt screen (not pictured) may ask the user toindicate whether the epinephrine has been administered, and the user mayanswer yes, once it has in fact been administered, or may indicate thatthe user cannot administer it, possibly because no autoinjector isavailable.

In either case, the mobile app may then, in an embodiment, present theuser with further actions to be taken in treatment of the episode (block3026) and provide various facilities to help the user with those actions(block 3030).

FIG. 31 depicts a treatment steps screen 3100 such as may be presentedin block 3026 (FIG. 30) according to embodiments of the invention. Thedepicted screen 3100 includes a timer 3110 that indicates the elapsedtime since the emergency was activated; in embodiments, the timer 3110may be present on all screens presented by a mobile app during anemergency.

The treatment steps screen 3100 may also include, e.g., a tab bar orbutton bar 3114, which may enable the user to switch between screensand/or views during the emergency. The depicted bar 3114 shows threeoptions: “Treatment” 3118, “Actions” 3122, and “Status” 3126. Asdepicted, the “Treatment” 3118 option is highlighted, indicated that thetreatment steps screen 3100 is current selected and displayed.

The treatment steps screen 3100 displays a list of steps 3130 that maybe advised in responding to an allergic emergency. As depicted, thefirst step 3134, injecting the subject with epinephrine, has been taken,but the others have not. Each step 3130 includes a textual description3136 of the action to be taken, and a checkbox 3138 indicating whethertaking that action has been recorded. Because FIG. 31 depicts atreatment steps screen 3100 immediately after administration ofepinephrine, the checkbox 3138 in this step 3134 is checked, but theothers are not.

It will be appreciated that the displayed steps are part of an exemplarytreatment protocol selected in connection with an embodiment of theinvention, and that other treatment protocols are possible in connectionwith embodiments of the invention. It will also be appreciated that oneor more other steps may be presented in addition to, or instead of, someor all of the steps 3130 that FIG. 31 depicts if the user indicates,e.g., in block 3022 (FIG. 30), that epinephrine has not beenadministered; for example, the mobile app may instruct the user, e.g.,to stay with the subject and call 911 immediately.

FIG. 32 depicts a treatment actions screen 3200 such as may bedisplayed, e.g., during step 3030 (FIG. 30), in an embodiment of theinvention. As depicted, the “Actions” 3122 item is highlighted toindicate selection of this screen. The treatment actions screen 3200, asdepicted, includes a list of actions 3210 that the user may select.

In an embodiment of the invention, if the user selects the “LocateDevices” action 3214, the mobile app may display, e.g., a map (notpictured) of the area near the user, and the map may indicateautoinjectors (with stickers) that are near the user, or, alternatively,near the subject. The display may include, e.g., stickers that areassociated with the subject, home base stations that are associated withsubject and/or currently hold an autoinjector that is associated withthe subject, and/or public base stations that contain useableautoinjectors. In an embodiment, any nearby stickers that are not yet in“Find My Pen” mode may receive a command to enter that mode.

In an embodiment of the invention, a subject may be able to indicate awillingness to allow others to use one of that subject's autoinjectorsin an emergency. In that case, a user, associated with a second subject,who selects the “Locate Devices” action 3214 may also see on the map thelocation of the first subject and/or one or more home base stationsassociated with the first subject.

Similarly, in an embodiment of the invention, a user selecting the“Locate Urgent Care” action 3218 may be presented, e.g., with a map (notpictured) showing one or more urgent care centers near the user and/orsubject. The display with the map may further include information aboutone or more of the indicated urgent care centers.

The action taken in response to selection of the “Call 911” action 3222may be expected to vary depending on the embodiment of the invention.For example, in an embodiment, it may cause the smartphone to make anemergency call. Alternatively, in an embodiment, it may connect the userwith an operator in a dispatch center, who may summon emergency aid onbehalf of the subject; this connection may, in embodiments of theinvention, use voice and/or text messaging.

In an embodiment of the invention, the effect of choosing the “Call 911”action 3222 may be to automatically (i.e., without further humanintervention) cause a message to be sent to emergency services to summonhelp to a subject. But it will be appreciated that applicable law and/orregulations may limit the use of such embodiments.

In an embodiment of the invention, the effect of the “Call Allergist”action 3226 may be to cause the device to attempt to contact thesubject's allergist, e.g., by having the smartphone call a stored phonenumber that is associated with the allergist.

FIG. 33 depicts an emergency status screen 3300, e.g., as a mobile appmay present to a user in an embodiment of the invention. The emergencystatus screen may present, e.g., a scrollable timeline 3310 of eventssince the emergency was activated. As depicted, one displayed event 3320includes a text message 3324 that indicates that the subject wasinjected with epinephrine. This event includes a time/date stamp 3328;in embodiments of the invention, any or all events in the timeline 3310may be displayed, e.g., with a similar time/date stamp.

In an embodiment of the invention, an event such as this 3320 may begenerated automatically, e.g., in response to a user's indication thatan injection has been administered to the subject. In embodiments of theinvention, similar events may be automatically registered and broadcast,e.g., upon a user's taking any or all actions such as may be madeavailable via a screen 3200 such as FIG. 32 depicts.

Returning to FIG. 33, the timeline 3310 includes an event 3340indicating that a team member has been detected near the subject. Theevent 3340 includes a textual description 3344 of the event and a map3348 that indicates the location of the team member. That location, inan embodiment such as FIG. 33 depicts, may be indicated, e.g., by anindicator that conveys additional information. For example, theindicator 3352 in FIG. 33 includes icons that mean that the subject, anidentified team member, and an autoinjector are all at the indicatedlocation. A location-related event 3340, e.g., as depicted, may includeone or more elements—such as a drop-down list 3356 and/or a collection3360 of user pictures—that may allow a user to see the location of anyone or more members of the subject's team.

As depicted, the emergency status screen may include a text entry area3370, which may in an embodiment allow a user to send other statusupdates, e.g., as the user might compose and send a text message.

Any or all actions and/or events that take place during an emergency,including (but not limited to) the actions and events described above,may be sent to support infrastructure and logged, e.g., as describedelsewhere. Some or all of the logged information may be passed along toteam members, e.g., as alerts, particularly the beginning and end ofemergency status. Status updates from one team member may be availableto other team members, e.g., through their own smartphones.

Returning to FIG. 30, a user who is not sure that an allergic reactionis taking place may in embodiments of the invention be guided throughdiagnosing the possible reaction. FIG. 34 depicts a scrollable screen3400 according to an embodiment of the invention that includes a list3410 of potential symptoms 3420 of anaphylaxis. Each potential symptom3420 includes a description 3422 and a checkbox 3424. As depicted, thelist 3410 also includes an item 3430 allowing the user to indicate thatthe subject is not experiencing any of the listed severe symptoms.

At the bottom of the screen 3400, in an embodiment such as FIG. 34depicts, is a button 3440 labeled “Next” that may, e.g., submit the formfor evaluation. The button 3440 may be disabled until any one or moreentries in the list 3410 are selected.

In response to selection of the “Next” button 3440, the mobile app (or,alternatively, the support infrastructure) may evaluate the submissionto determine whether the subject may be experiencing anaphylaxis. In anembodiment of the invention, the subject may be deemed to be inpotential anaphylaxis if any of the symptoms (other than “None”) hasbeen selected. Alternatively, it will be appreciated by those skilled inthe medical arts that some listed symptoms may be generally consideredstrong indicators of potential anaphylaxis and others may be generallyconsidered to be weak indicators of it. Thus, in an embodiment, asubject may be deemed to be in anaphylaxis if any two weak indicatorshave been selected and/or if any one strong indicator has been selected.

In either case, if the user is deemed as a result of this inventory ofsymptoms to be in anaphylaxis, the mobile app in an embodiment of theinvention may, e.g., proceed directly to block 3022 in FIG. 30,activating an emergency and directing the user to inject the subjectwith epinephrine.

In an embodiment, one or more sensors may be provided that may becapable of automatically detecting one or more symptoms, e.g., ofanaphylaxis. Such sensors may be, e.g., included in a wearable device,separate devices that may interact with a smartphone or other device viaa wired and/or wireless connection, and/or be common parts ofsmartphones or other electronic devices (e.g., a smartphone microphoneand/or camera). In such an embodiment, e.g., a mobile app and/or supportinfrastructure may algorithmically analyze one or more inputs from oneor more such sensors, determine that the input reflects one or morebiological indicators of anaphylaxis, and report potential anaphylaxisbased on one or more indicators that may include, without limitation,cardiac output, heart rate, blood pressure, blood oxygen saturation,respiration rate, sound, flushing on the skin, hives on the skin, skintemperature, and perspiration. In some embodiments, anaphylaxisdetection wearable device 60 may comprise one or more sensors including,but not limited to, electrocardiogram (EKG) sensors,electroencephalogram (EEG) sensors, pulse oximetry sensors,photoplethysmography sensors, skin color sensors, and bioimpedancesensors.

For example, it is known to use a smartphone camera to obtainphotoplethysmograms, breathing rate, and blood oxygen saturation, amongother physical parameters. In an embodiment, anaphylaxis may be detectedby an increase in heart rate, an initial increase in blood pressurefollowed by a rapid decrease, an oxygen saturation of less than 99%, anincrease in breathing rate, a decrease in skin temperature, and anincrease in perspiration. In some embodiments, anaphylaxis may furtherbe identified by a decrease in cardiac output.

In some embodiments, an anaphylaxis detection wearable device may be inthe form of a wearable chest patch or a necklace. In these embodiments,the anaphylaxis detection wearable device may comprise a stethoscopefeature to monitor wheezing and stridor to detect an early onset of ananaphylactic reaction. The stethoscope feature may comprise a microphonewith a sensitivity of at least. In an embodiment, acoustic signal may becollected and be processed by noise cancelling and filtering algorithms.Various features such as frequency and amplitude may be extracted fromthe processed acoustic signals. Based on the signature of the sound,anaphylaxis may be identified. In certain embodiments, the anaphylaxisdetectable wearable device may further comprise an accelerometer todetect motion of the subject and eliminate false positives.

In an embodiment, an anaphylaxis detection wearable device may compriseskin sensors and bioimpedance sensors to monitor flushing, perspiration,and hives on the skin. The skin sensors may comprise a camera and amemory comprising color recognition algorithms. The bioimpedance sensorsmay be configured to detect electrodermal activity.

In certain embodiments, an anaphylaxis detection algorithm is provided.A probability scaling from 0% to 100% may be calculated based on acombination of a subject's history of asthma and prior anaphylacticreactions, in addition to the frequency of stridor, the extent ofperipheral vasoconstriction, a slight decrease in skin temperature, adecrease in blood pressure, and a decrease in cardiac output.

It will be appreciated that managing a potentially life-threateningcondition such as severe food allergies may be best done by a team,which may include a subject's family. This may be particularly true whenthe subject is a minor child. Thus, systems and methods according toembodiments of the invention may involve a defined group of people otherthan the subject, and these people, together with the subject, mayconstitute the subject's team.

More precisely, a subject's team in connection with an embodiment of theinvention may be those people who have smartphones or other devices witha mobile app installed and who have registered, e.g., with supportinfrastructure, as members of a subject's team. Members of a team mayhave different roles and/or levels of access to shared data, and theseroles and/or levels may be managed, e.g., by a team member withadministrative privileges, through a suitable user interface (notpictured).

For example, in an embodiment, a subject may have full access to all thedata in the mobile app through cloud servers. Progressively narrowerlevels of access may be granted, e.g., to immediate family, friends,level 1 caregivers, level 2 caregivers, and other team members.Immediate family may include a child, parents, and siblings of asubject, although, in an embodiment of the invention, the parents of asubject who is a minor child may have access that is identical to thatof the subject. Friends may include invited friends of a subject. Level1 caregivers may include, e.g., a school nurse, a babysitter, a teacher,a coach, a camp counsellor, grandparents, a parent of a friend, adoctor, or an allergist. Level 2 caregivers may include, e.g., a newbaby sitter, a new teacher, a parent of a playmate, or a parent of afriend whom the subject is having, e.g., a sleep-over party with. Otherteam members may include a friend of a friend, a cook at the school ofsubject, a waiter at a restaurant, or an emergency responder.

Team members may receive notifications of events, e.g., as described.Notifications may be filtered based, e.g., on team members' respectivelevels, the type of notification, and/or other factors that may beconfigured, e.g., through an appropriate user interface (not pictured)of the mobile app and/or a web site.

In some embodiments, the software components in the system may becapable of determining statuses and intelligently routing notificationsin accordance with the present disclosure based on the presence of asubject, a medical device, a caregiver, a preset time schedule, or acombination of the above. In certain embodiments, the softwarecomponents may be capable of managing notifications based on acombination of a time-based schedule and a physical location of amedical device. In some embodiments, the software components may becapable to determine which connected devices need to receive anotification. In another embodiment, application stored on a smartmobile device may share with a caregiver a link to a secure website viaSMS or email. In accordance with the examples of this disclosure, thesystem may monitor the presence or location of a device in combinationwith the presence or location of a subject or a caregiver. In someembodiments, the software components may be configured to customize anallergy action plan based on the subject and the team members'preferences.

This disclosure refers to particular embodiments and examples, but itwill be understood by those skilled in the art that various changes maybe made and equivalents may be substituted for elements thereof withoutdeparting from the scope of the present disclosure. In addition, manymodifications may be made to adapt a particular situation or material tothe teachings of the present disclosure without departing from the scopeof the present disclosure.

Therefore, it is intended that the present disclosure not be limited tothe particular embodiments disclosed as the best mode contemplated forcarrying out the present disclosure, but that the present disclosurewill include all embodiments falling within the scope and spirit of theappended claims.

EXAMPLES

Embodiments of the invention may include, e.g., components and/oractivities such as described above. The following examples furtherdescribe embodiments of the invention and/or their components and/oruses.

Example I

The use of a system comprising a sticker attached to an epinephrine penand a smartphone by a subject and an immediate family member isdescribed. The smart device is possessed by an immediate family member.In this scenario, the subject leaves home to a destination.

Referring to FIG. 35A, initially, the subject and immediate familymember are at home. Accordingly, the sticker and smartphone areconnected and are in the same region. The smart device reports the “inregion” status to the cloud server, Based on this status, nonotifications are made in the system.

Next, in FIG. 35B, the subject carries the sticker-attached epinephrinepen with him and moves in transit away from the immediate family member.The smart device eventually loses connection with the sticker, As aresult, the smartphone determines that the epinephrine pen is out of theregion. The smartphone then reports to cloud server the “out of region”status, e.g., via a base station, smartphone, or other connected device,and the location where it last co-localized with sticker, along with atimestamp. Based on this status, a status change notification isprovided to subject on the smartphone.

In FIG. 35C, The subject arrives at the destination with thesticker-attached epinephrine pen. Because the sticker is neitherconnected to the smartphone nor cloud server, no new notifications aregenerated.

Finally, in FIG. 35D, the subject returns to home carrying thesticker-attached epinephrine pen. The sticker and the smartphone are inthe same region again and re-establishes connection with one another.Accordingly, the smartphone reports the “in region” status to the cloudserver, Based on this status, a status change notification is providedto the subject on the smartphone.

Example 2

The use of a system comprising a sticker attached to an epinephrine pen,a first smartphone and a second smartphone by a subject and an immediatefamily member is described. Smart devices are possessed by the immediatefamily member and the subject, respectively. In this scenario, thesubject leaves home to a destination,

Referring to FIG. 36A, initially, the subject and immediate familymember are at home, Accordingly, the sticker and smart devices areconnected and are in the same region. Smartphone both report the “inregion” status to the cloud server, Based on this status, nonotifications are made in the system.

Next, referring to FIG. 36B, the subject carries the sticker-attachedepinephrine pen and a smartphone with him and moves in transit away fromimmediate family member, As the smartphone loses connection with thesticker after subject is more than about 30 feet away, the smartphoneremains connected with the sticker. The smartphone determines that theepinephrine pen is out of the region and reports the “out of region”status to the cloud. However, because the smartphone remains in regionwith the sticker, the “out of region” status is overridden. As a result,the smartphone provides to the immediate family member a notificationthat both the subject and the epinephrine pen are out of region, Theimmediate family member has the option to review the location ofsmartphone as the subject is in transit to destination,

Referring to FIG. 36C, the subject arrives at the destination havingonly the smartphone with him but not the sticker-attached epinephrinepen. Both smartphones lose connection with the sticker. Because thesmartphone is the last smart device that lost connection with thesticker, the smartphone would report to the cloud the “out of region”status and the location where it last co-localized with the sticker,along with a timestamp. As a result, the smartphone provides to thesubject a notification that the epinephrine pen is out of region. Anotification that the subject has separated from his epinephrine pen isalso provided to the smartphone to the attention of immediate familymember,

Referring to FIG. 36D, the subject successfully recovers his epinephrinepen. Therefore, the sticker and smartphone are once again in the sameregion and re-establishe connection with each other. Upon re-connection,the smartphone reports the “in region” status to the cloud server, As aresult, the smartphone provides to the subject a notification confirmingthat the epinephrine pen is once again in region. A notification thatthe subject has recovered his epinephrine pen is also provided to thesmartphone to the attention of immediate family member,

Referring to FIG. 36E, the subject, carrying a smartphone, is separatedfrom the epinephrine pen attached to a the sticker for more than 30feet. Both smartphones lose connection with the sticker. Because thesmartphone is the last smart device that lost connection with thesticker, the smartphone would report to the cloud the “out of region”status and the location where it last co-localized with the sticker,along with a timestamp. As a result, the smartphone provides to thesubject a notification that the epinephrine pen is out of region. Anotification that the subject has separated from his epinephrine pen isalso provided to the smartphone to the attention of immediate familymember,

Example 3

The use of a system comprising a the sticker attached to an epinephrinepen, a wearable, and a smartphone by a subject and an immediate familymember is described. The subject possesses a wearable, A smartphone ispossessed by an immediate family member, In this scenario, the subjectleaves home to a destination,

Referring to FIG. 37A, initially, the subject and the immediate familymember are at home, Accordingly, the sticker, wearable, and smartphoneare connected and are in the same region. The smartphone reports the “inregion” status to the cloud server, Based on this status, nonotifications are made in the system.

Next, referring to FIG. 37B, the subject carries the sticker-attachedepinephrine pen and wearable with him and moves in transit away from theimmediate family member, As the smartphone loses connection with boththe sticker and the wearable after the subject is more than about 30feet away, the smartphone determines that the epinephrine pen is out ofthe region and reports the “out of region” status and the location whereit last co-localized with the sticker to the cloud, As a result, thesmartphone provides to immediate family member a notification that boththe subject and the epinephrine pen are out of region.

Referring to FIG. 37C, the subject arrives at the destination havingonly the wearable with him but not the sticker-attached epinephrine pen.The wearable loses connection with the sticker, which would trigger thewearable to vibrate. Such vibrations would notify the subject that hehas separated from the epinephrine pen. However, because the wearable isnot connected to the cloud, no additional notification would be providedto the smartphone.

Referring to FIG. 37D, the subject successfully recovers his epinephrinepen. Therefore, the sticker and wearable are once again in the sameregion and re-establish connection with one another. Upon re-connection,the wearable provides to the subject a notification confirming that theepinephrine pen is once again in region. Again, because the wearable isnot connected to the cloud, no additional notification would be providedto the smartphone.

Referring to FIG. 37E, the subject wearing the wearable is separatedfrom the epinephrine pen attached to a the sticker for more than 30feet. The wearable loses connection with the sticker, which wouldtrigger the wearable to vibrate. Such vibrations would notify thesubject that he has separated from the epinephrine pen. However, becausethe wearable is not connected to the cloud, no additional notificationwould be provided to smartphone.

Example 4

The use of a system comprising a sticker attached to an epinephrine pen,a first smartphone and a second, other smartphone by a subject, animmediate family member, and a level 1 caregiver is described. Thesmartphones are possessed by an immediate family member and a level 1caregiver, respectively. In this scenario, the subject leaves home to adestination,

Referring to FIG. 38A, initially, the subject and immediate familymember are at home, and the level 1 caregiver is present at destination,Accordingly, the sticker and smartphone are connected and are in thesame region. The smartphone reports the “in region” status to the cloudserver, Although the other smartphone is paired to the sticker butdisconnected, the level 1 caregiver has not yet been grantedresponsibility of the subject, In this case, the cloud server wouldallow the status reported by the smartphone to override the statusreported by the other smartphone. Based on the “in region” status, nonotifications are made in the system.

Next, referring to FIG. 38B, the subject carries the sticker-attachedepinephrine pen with him and moves in transit away from the immediatefamily member, As the smartphone loses connection with the sticker afterthe subject is more than about 30 feet away, both smartphones aredisconnected with the sticker. The smartphone determines that theepinephrine pen is out of the region and reports the “out of region”status and the location where it last co-localized with the sticker tothe cloud, As a result, the smartphone provides to the immediate familymember a notification that both the subject and the epinephrine pen areout of region.

Referring to FIG. 38C, the subject arrives at the destination carryingthe sticker-attached epinephrine pen. Because the sticker is paired withthe other smartphone, a connection between the sticker and the othersmartphone would be established upon the arrival of the subject atdestination, The level 1 caregiver would be given the option to acceptthe transferred responsibility to track the epinephrine pen. Uponacceptance of the responsibility, the other smartphone would report tothe cloud that the epinephrine pen is “in region.” Based on the “inregion” status, the immediate family member would be notified throughsmartphone that the level 1 caregiver is in region with the epinephrinepen.

Referring to FIG. 38D, the subject is in transit and is separated fromthe epinephrine pen attached to a the sticker for more than 30 feet. Theother smartphone remains connected with the sticker. Accordingly, noadditional notification would be provided to either smartphone.

Example 5

The use of a system comprising a sticker attached to an epinephrine pen,three smartphones by a subject, an immediate family member, and a level1 caregiver is described. The smartphones are possessed by the immediatefamily member, the subject, and the level 1 caregiver, respectively. Inthis scenario, the subject leaves home to a destination,

Referring to FIG. 39A, initially, the subject and the immediate familymember are at home, and the level 1 caregiver is present at thedestination, Accordingly, the sticker and the first and secondsmartphones are connected and are in the same region. The first andsecond smartphones report the “in region” status to the cloud server,Although the third smartphone is paired to the sticker but disconnected,the level 1 caregiver has not yet been granted responsibility of thesubject, In this case, the cloud server would allow the statusesreported by the first and second smartphones to override the statusreported by the third smartphone. Based on the “in region” status, nonotifications are made in the system.

Next, referring to FIG. 39B, the subject carries the sticker-attachedepinephrine pen as well as the second smartphone with him and moves intransit away from the immediate family member, As the first smartphoneloses connection with the sticker after the subject is more than about30 feet away, the second smartphone remains connected with the sticker.The first smartphone determines that the epinephrine pen is out of theregion and reports the “out of region” status to the cloud. However,because the second smartphone remains in region with the sticker, the“out of region” status is overridden. As a result, the first smartphoneprovides to the immediate family member a notification that both thesubject and the epinephrine pen are out of region. The immediate familymember has the option to review the location of the second smartphone asthe subject is in transit to destination,

Referring to FIG. 39C, the subject arrives at the destination carryingboth the sticker-attached epinephrine pen and the second smartphone. Thesecond smartphone continues to report an “in region” status to thecloud, Because the sticker is paired with the third smartphone, aconnection between the sticker and the third smartphone would beestablished upon the arrival of the subject at the destination, Thelevel 1 caregiver would be given the option to accept the transferredresponsibility to track the epinephrine pen. Upon acceptance of theresponsibility, the third smartphone would report to the cloud that theepinephrine pen is “in region.” Based on the “in region” statusesprovided by the second and third smartphones, the immediate familymember would be notified through the first smartphone that the subjectand the level 1 caregiver are in region with the epinephrine pen.

Referring to FIG. 39D, the subject carrying the second smartphone isseparated from the epinephrine pen attached to a the sticker for morethan 30 feet. The second smartphone is disconnected from the sticker.Nonetheless, the second and third smartphones are within a 1 mile safezone distance, and the third smartphone remains connected to thesticker. Accordingly; the second smartphone determines that the stickerdevice is still “in region.” Accordingly, no additional notificationwould be provided to any smartphones.

Finally, referring to FIG. 39E, the subject carrying the secondsmartphone is in transit and is outsize of the 1 mile safe zone asdefined by the co-localization of the third smartphone and the sticker.The third smartphone is the only device that is connected with thesticker. The second smartphone determines that the sticker is “out ofregion,” and reports such status information to cloud server, As aresult, smartphones provide to all the team members a notification thatboth subject has left the epinephrine pen with level 1 caretaker,

Example 6

The use of a system comprising a sticker attached to an epinephrine pen,two smartphones, and a wearable by a subject, an immediate familymember, and a level 1 caregiver is described. The first and secondsmartphones are possessed by the immediate family member and the level 1caregiver, respectively. In this scenario, the subject leaves home to adestination,

Referring to FIG. 40A, initially, the subject and the immediate familymember are at home, and the level 1 caregiver is present at thedestination, Accordingly, the sticker, wearable, and the firstsmartphone are connected and are in the same region. The firstsmartphone reports the “in region” status to the cloud server, Althoughthe second smartphone is paired to the sticker but disconnected, thelevel 1 caregiver has not yet been granted responsibility of subject, Inthis case, the cloud server would allow the status reported by the firstsmartphone to override the status reported by the second smartphone.Based on the “in region” status, no notifications are made in thesystem.

Next, referring to FIG. 40B, the subject carries the sticker-attachedepinephrine pen as well as the wearable with him and moves in transitaway from the immediate family member, As the first smartphone losesconnection with the sticker after the subject is more than about 30 feetaway, the wearable remains connected with the sticker. The firstsmartphone determines that the epinephrine pen and wearable are out ofthe region and reports the “out of region” status to the cloud, Thefirst smartphone further reports the location where it last co-localizedwith the sticker to the cloud, As a result, the first smartphoneprovides to immediate family member a notification that both subject andthe epinephrine pen are out of region.

Referring to FIG. 40C, the subject arrives at the destination carryingthe sticker-attached epinephrine pen and wearing the wearable. Becausethe sticker is paired with the second smartphone, a connection betweenthe sticker and the second smartphone would be established upon thearrival of subject at the destination, The level 1 caregiver would begiven the option to accept the transferred responsibility to track theepinephrine pen. Upon acceptance of the responsibility, the secondsmartphone would report to the cloud that the epinephrine pen is “inregion.” Based on the “in region” statuses provided by the secondsmartphone, the immediate family member would be notified through thefirst smartphone that the subject and the level 1 caregiver are inregion with the epinephrine pen.

Referring to FIG. 40D, the subject wearing the wearable is separatedfrom the epinephrine pen attached to a sticker for more than 30 feet.The wearable loses connection with the sticker, which would trigger thewearable to vibrate. Such vibrations would notify subject that he hasseparated from the epinephrine pen. However, because wearable is notconnected to the cloud, no additional notification would be provided tothe first smartphone or the second smartphone. Indeed, because thesecond smartphone remains connected to the sticker, the secondsmartphone determines that the sticker device is still “in region.”Accordingly, no additional notification would be provided to any smartdevices.

Finally, referring to FIG. 40E, the subject wearing the wearable is intransit and is outside of the 1 mile safe zone as defined by theco-localization of the second smartphone and the sticker. The secondsmartphone is the only device that is connected with the sticker. Thewearable continues to vibrate. Such vibrations would notify the subjectthat he has separated from the epinephrine pen. However, because thewearable is not connected to the cloud, no additional notification wouldbe provided to the first smartphone or the second smartphone. Indeed,because the second smartphone remains connected to the sticker, thesecond smartphone determines that the sticker is still “in region.”Accordingly, no additional notification would be provided to any smartdevices.

Example 7

The use of a system comprising a the sticker attached to an epinephrinepen, two smartphones, and a the wearable by a subject, an immediatefamily member, and a level 1 caregiver is described. The smartphones arepossessed by the immediate family member and the level 1 caregiver,respectively. In this scenario, the subject leaves home to adestination,

Referring to FIG. 41A, initially, the subject and the immediate familymember are at home, and the level 1 caregiver is present at thedestination, Accordingly, the sticker, the wearable, and the firstsmartphone are connected and are in the same region. The firstsmartphone reports the “in region” status to the cloud server, Althoughthe second smartphone is paired to the sticker but disconnected, thelevel 1 caregiver has not yet been granted responsibility of thesubject, In this case, the cloud server would allow the status reportedby the first smartphone to override the status reported by the secondsmartphone. Based on the “in region” status, no notifications are madein the system.

Next, referring to FIG. 41B, subject carries the sticker-attachedepinephrine pen as well as the wearable with him and moves in transitaway from the immediate family member, As the first smartphone losesconnection with the sticker after the subject is more than about 30 feetaway, the wearable remains connected with the sticker. The firstsmartphone determines that the epinephrine pen and the wearable are outof the region and reports the “out of region” status to the cloud, Thefirst smartphone further reports the location where it last co-localizedwith the sticker to the cloud, As a result, the first smartphoneprovides to the immediate family member a notification that both subjectand the epinephrine pen are out of region.

Referring to FIG. 41C, the subject arrives at the destination carryingthe sticker attached epinephrine pen and wearing the wearable. Becausethe sticker is paired with the second smartphone, a connection betweenthe sticker and the second smartphone would be established upon thearrival of the subject at the destination, The level 1 caregiver wouldbe given the option to accept the transferred responsibility to trackthe epinephrine pen. As a part of the responsibility transfer process,the level 1 caregiver would also define a safe time zone on the secondsmartphone. Upon acceptance of the responsibility, the second smartphonewould report to the cloud that the epinephrine pen is “in region.” Basedon the “in region” statuses provided by the second smartphone, theimmediate family member would be notified through the first smartphonethat the subject and the level 1 caregiver are in region with theepinephrine pen. The safe time zone information would also be providedto the wearable.

Referring to FIG. 41D, the subject wearing the wearable is separatedfrom the epinephrine pen attached to a the sticker for more than 30 feetduring a safe time zone as previously defined. The wearable losesconnection with the sticker, which would ordinarily trigger the wearableto vibrate. But the wearable would not vibrate during the safe timezone. The second smartphone remains connected to the sticker, hence, thesecond smartphone determines that the sticker device is still “inregion”. Accordingly, no additional notification would be provided toany smart devices.

Finally, referring to FIG. 41E, the subject wearing the wearable is intransit, The safe time zone is expired and the subject is outsize of the1 mile safe zone as defined by the co-localization of the secondsmartphone and the sticker. As a result, the wearable vibrates. Suchvibrations would notify the subject that he has separated from theepinephrine pen. Although the second smartphone remains connected to thesticker, the safe time zone has expired. Accordingly, the secondsmartphone determines that the subject is “out of region,” and reportssuch status information to cloud server, As a result, the smartphonesprovide to all the team members a notification that the subject has leftthe epinephrine pen with the level 1 caretaker,

1. A system for aiding an individual to manage the use of a medication,the system comprising a first device configured to adhere to a containerof the medication; and a second device configured to communicatewirelessly with the first device, the second device comprising one ormore processors and one or more computer-readable storage mediaelectronically coupled to at least one of the processors and encodedwith instructions that cause the second device at least to attempt toform a wireless connection with the first device, the instructionsfurther comprising both instructions that detect success of the attemptto establish a wireless connection with the first device and as aconsequence of this detection cause the second device to provide outputthat indicates that the second device is connected to the first device,and instructions that detect failure of the attempt to establish awireless connection with the first device and as a consequence of thisdetection cause the second device to emit an alert.
 2. The system ofclaim 1, wherein the container is a medical device.
 3. The system ofclaim 2, wherein the container is an autoinjector.
 4. The system ofclaim 3, wherein the autoinjector comprises epinephrine.
 5. The systemof claim 1, wherein: the second device comprises a locate button; andthe locate button, when pressed, causes the second device to transmit asignal to the first device, the signal comprising a command to the firstdevice to emit sound, light, or sound and light.
 6. The system of claim1, wherein the first device comprises a temperature sensor.
 7. Thesystem of claim 6, wherein the first device comprises: one or moreprocessors; one or more memories operatively coupled to at least one ofthe processors; and one or more computer-readable storage mediaoperatively coupled to at least one of the processors and encoded withinstructions that, when executed by at least one of the processors,cause the first device at least to store in at least one of the memoriesa temperature reading obtained from the temperature sensor, and based onthe temperature reading, emit a signal from the group that consists of atemperature warning signal and temperature damage signal.
 8. The systemof claim 7, wherein the first device is configured to emit thetemperature warning signal when the temperature sensor detects atemperature about 5% outside of a predetermined temperature range. 9.The system of claim 7, wherein the first device is configured to emitthe temperature damage signal when the temperature sensor detects atemperature about 10% outside of a predetermined temperature range. 10.The system of claim 1, wherein the second device is a base station. 11.The system of claim 10, wherein the alarm signal triggers the basestation to generate a sound.
 12. The system of claim 10, wherein thebase station comprises a light emitting diode (LED), and receiving thealarm signal causes the base station to illuminate the LED.
 13. Thesystem of claim 10, wherein the base station is configured to hold morethan one type of medical devices.
 14. The system of claim 1, wherein thesecond device is a wearable.
 15. The system of claim 14, wherein thewearable comprises a vibration module.
 16. The system of claim 15,wherein the alarm signal activates the vibration module.
 17. The systemof claim 14, wherein the wearable comprises an audible alarm.
 18. Thesystem of claim 17, wherein the alarm signal activates the audiblealarm.
 19. The system of claim 1, wherein the second device is a mobilephone.
 20. The system of claim 19, wherein the signal is communicated bythe mobile phone to a support infrastructure.
 21. The system of claim 10or claim 14, comprising a third device configured to communicate withthe second device, wherein the third device comprises: one or moreprocessors; and one or more computer-readable storage media operativelycoupled to at least one of the processors and encoded with instructionsthat, when executed by at least one of the processors, cause the thirddevice at least to try to establish a connection with the second device;determine the last visible location of the first device if a connectioncannot be established; record the location of the first device if aconnection is established; and report the location to a cloud server.22. The system of claim 21, wherein the third device is a mobile phone.23. The system of claim 10 or claim 14, further comprising a thirddevice configured to communicate with the second device, wherein thethird device comprises: one or more processors; and one or morecomputer-readable storage media operatively coupled to at least one ofthe processors and encoded with instructions that, when executed by atleast one of the processors, cause the third device at least toestablishing a connection with a support infrastructure; determine,using the connection with the support infrastructure, whether the seconddevice is in a safe zone; and provide, via the support infrastructure, anotification to the second device if the second device is determined tobe outside of the safe zone.
 24. The system of claim 23, wherein thesafe zone is defined by a geographical location.
 25. The system of claim23, wherein the safe zone is defined by a geographical location and atime schedule.
 26. The system of claim 23, wherein the third device is amobile phone.